Adverse events in pediatric osteopathy Thesis for the Master in Pediatric Osteopathy at the Osteopathie Schule Deutschland in cooperation with the University of Wales

Name: Sander Kales Year: KO11 Matrixnumber: 11088 Adress: Vorselaarstraat 21, 1066 ST Amsterdam Email: [email protected]

Adverse events in pediatric osteopathy

DECLARATION This work has not previously been accepted in substance for any degree and is not being concurrently submitted in candidature for any degree. Signature Date

STATEMENT 1 This thesis is the result of my own investigations, except where otherwise stated. If other Sources are used, they are acknowledged in the continuous text. A bibliography of the resources is appended. Signature Date

STATEMENT 2 I hereby give consent for my thesis, if accepted, to be available for photocopying and for interlibrary loan, and for the title and summary to be made available to outside organisations. Signature Date

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Adverse events in pediatric osteopathy

I. Table of Content I.

Table of Content………………………………………………………………2

II.

Foreword……………………………………………………………………….5

III.

Tabels and Figures……………………………………………………………6

IV.

Abstract………………………………………………………………………...7

1. Osteopathy in children. Introduction and incentive 1.1 What is Osteopathy……………………………………………………………….8 1.1.1 Definition………………………………………………………………...8 1.1.2 Is Osteopathy a form of Medicine or is it Osteopathic Therapy?.....8 1.1.3 Osteopathic philosophy………………………………………………..9 1.2 Educational level of pediatric osteopaths in the Netherlands……………….11 1.2.1 Pediatric Physical Therapy (PT)…………………………………….12 1.2.2 Pediatric Medicine…………………………………………………….12 1.2.3 What is the level of paediatric osteopathy in the Netherlands?.....14 1.2.4 Conclusion chapter 1…………………………………………………16 2. Efficacy Studies and side effects…………………………………………………………17 2.1 Efficacy Studies………………………………………………………………….18 2.1.1 Treatment bio-mechanical / fascial………………………………….18 2.1.2 Treatment of organ connective tissue………………………………19 2.1.3 Metabolic treatment: otitis media……………………………………22 2.1.4 Review of neurological studies and Osteopathy…………………..23 2.2. Side effects or adverse events………………………………………………...24 2.2.1 Description of side effects……………………………………………24 2.2.2 Influence on the assessment of side effects……………………….24 2.2.3 Environmental Factors………………………………………………..25 2.2.4 Adverse events in manual techniques……………………………...25 2.2.5 Adverse events in manual therapies………………………………..26 2.3 Who are the people using osteopathy?.......................................................27 2.4 Survey of parents experience………………………………………………….29 2.5 Rubenstein questionnaire………………………………………………………29 3. Hypothesis………………………………………………………………………………….30

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4. Methods……………………………………………………………………………………..31 4.1 Type of study……………………………………………………………………..31 4.2 Participants……………………………………………………………………….31 4.2.1 The osteopaths……………………………………………………….31 4.2.2 The patients; In -and Exclusion criteria…………………………….31 4.3 Parameters……………………………………………………………………….31 4.4 Measurement…………………………………………………………………….32 4.5 Measurement personel………………………………………………………….32 4.6 Intervention……………………………………………………………………….33 4.7 Procedure ………………………………………………………………………...33 4.8 Statistics…………………………………………………………………………..36 4.8.1. Data analysis……………………………………………………………..36 4.8.2 Type of Data………………………………………………………………36 4.8.3 Type of statistical tests…………………………………………………..37 4.9 Time schedule……………………………………………………………………37 5. Ethical Aspects……………………………………………………………………………..38 6. Results………………………………………………………………………………………39 6.1 First visit…………………………………………………………………………….39 6.2 Conclusion after the treatments………………………………………………….44 7. Discussion and Conclusion……………………………………………………………….49 8. Bibliografie………………………………………………………………………………….52 9. Appendix……………………………………………………………………………………58

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II. Foreword The master study at the Osteopathie Schule Deutschland was a long and hard working journey that has taken more than three years now. I would like to thank the teachers and Mrs. Bettina Thiel for having the patience to work with me on this thesis. This research is done in collaboration with the Department of Pediatrics at the Hospital of Nieuwegein, mrs. Ellen Tromp as statstician, the University of Twente and the Louis Bolk Institute. The Louis Bolk Institute is conducting this study in Norway and Sweden, These results will be added in an article to be published in 2016. This study could not have been done without the effort of the twenty seven osteopaths who collected the data. Also I would like to thank Dr. Arine Vlieger and Dr. Nielske Weggelaar, paediatricians, for their effort in making this study possible, and accompanying me on every step of the way. Finally I would like to thank my wife Hilje and my five children for having the patience with me and putting up with so many hours without their father/ husband.

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III. Tabels and Figures Table 1.1 Overview of Osteopathic Training……………………………………………….13 Figure 4.1 Flow chart of the procedure……………………………………………………..32 Table 4.7 Numerical classification of complaints………………………………………….33 Table 4.8 Complaints…………………………………………………………………………34 Table 4.9 Side effects………………………………………………………………………...35 Figure 7.1 Age of the children……………………………………………………………….38 Figure 7.2 Fear of the treatment…………………………………………………………….39 Figure 7.3 Earlier visits to other specialties………………………………………………..39 Table 7.1 With which complaints are you visiting the osteopath?.................................40 Figure 7.4 Severity of complaint 1………………………………………………………….41 Figure 7.5 Severity of complaint 2 …………………………………………………………42 Figure 7.6 Expectation of the treatment …………………………………………………..42 Figure 7.7 Satisfaction after first treatment………………………………………………..43 Figure 7.8 Satisfaction after second treatment……………………………………………43 Figure 7.9 Satisfaction after third treatment……………………………………………….43 Figure 7.10 Side effects after first treatment ………………………………………………44 Figure 7.11 Amount of adverse events…………………………………………………….44 Figure 7.12 How long did side effects last…………………………………………………45 Figure 7.13 Crying side effect……………………………………………………………….46 Figure 7.14 Sleeping side effect…………………………………………………………….46 Figure 7.15 Restlessnes……………………………………………………………………..46

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IV. Abstract The inspiration of this thesis comes from two severe cases that took place in the Netherlands during the past seven years. In 2005, a baby died in the hospital after treatment by a Cranio Sacral therapist. In 2009, a baby of three months, died after a manipulative treatment by a Manual Therapist (Micha Holla 2009). The technique which has been used in both cases, is the "folding technique” taught in the training of Upledger in the Netherlands, in which the baby is forced in a fetal position with a full flexion of the neck. In subsequent media hype osteopathy was included in the list of practitioners who work on the necks of children. This resulted in a negative association with osteopathy and subsequent fewer referrals by physicians to osteopaths. Physicians, especially pediatricians, rated osteopathy as a harmful form of treatment. The incentive of this thesis is that osteopathy, even though both treatments were no osteopathic treatments, was accused and found guilty, while the "folding technique" (Micha Holla 2009) is in fact not even taught to osteopaths. Osteopathy is not a technique but encompasses both a philosophy ,which is different from regular medicine, and a skill which is holistic mostly in its diagnosis. The current study into adverse events in pediatric osteopathy is done through an inventory of pediatric background of osteopaths and pediatric osteopaths in the Netherlands. A comparison is made between the training of pediatric and regular osteopaths with pediatricians and pediatric physiotherapists. Thereafter an analysis was made to see if there was a difference in amount of adverse events between regular osteopaths and pediatric trained osteopaths. This was not the case (Micha Holla 2009). The effect of pediatric osteopathic treatment in children is assessed by a literature study. There are, for example, studies that have investigated the effect of osteopathic manual treatment for certain symptoms in children. These studies are inventoried. It is about finding the best evidence for clinical questions (Hawk, Schneider et al. 2009). In this study the safety of osteopathic treatment in the Netherlands in patients aged zero to fourteen is investigated by a questionnaire about side effects and adverse events. This was performed in twenty seven practices of osteopaths across the country. 785 treatments were analyzed. The results show that there were no serious or mild but just minor adverse events in only twenty percent, which lasted on average not more than three days. Recommendations are made to further improve osteopathy in pediatric patients and to make sure that osteopathic treatments remain safe.

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Adverse events in pediatric osteopathy

Chapter 1 Osteopathy in children. Introduction and incentive 1.1 What is Osteopathy? In order to get a clearer picture of the events that happened with the two babies an analysis is made of what osteopathy is, what its philosophy is and in what way the osteopath differs from other manual therapists, that were involved in these cases. 1.1.1 Definition The definition of Osteopathy, according to the Occupational Competency Profile version 1.0 of the NVO in the Netherlands (Advies 2009): "Osteopathy is a diagnostic and a treatment method in which the manual patiënt approach aims to optimize and maintain the health of the patiënt. She engages in selfregulatory mechanisms of the human being. Osteopathy is based on the concept that man as living organism is a structural (anatomical) and functional (physiological) unit. the focus of osteopathy is on the approach to the optimization of the health of the patiënt with the purpose of healing the sick. Osteopathy is thus a philosophy and a way of thinking." According to this definition Osteopathy has a different approach than regular medicine in that it is about optimizing health and not about treating disease. This optimization is done in a holistic way. 1.1.2 Is Osteopathy a form of Medicine or is it Osteopathic Therapy? Osteopathy is a profession which was founded in 1892. At that time it was a particular form of general medicine in the United States. Its founder A.T. Still was a surgeon (McKone, 2001). Today, in the Netherlands, it can be studied as a specialisation of physical therapy, or general medicine. A therapy is a part of medicine that deals with treating or curing diseases or relief of symptoms. The focus is on one part of medicine, which is to do the treatment and not the diagnostic phase of the process. This process of diagnostics is an essential part in medicine (Wikipedia). The distinction between therapy and medicine is relevant for the knowledge and expertise of the osteopath. Diagnostics, and then choosing the appropriate form of treatment precedes the manual aspect. Generally the osteopath also focuses on

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nutrition, lifestyle advice, and certainly the right time to refer to other health care workers/ physicians. There have been several osteopaths in the past that have limited osteopathic medicine to techniques and founded a form of therapy (Palmer: Chiropractic, Van der Bijl: Manual Therapy, Sickesz: Orthomanual medicine). Literally manual therapy is a form of therapy that is done with ones hands. Therefore Chiropractic, Orthomanual medicine, Craniosacral therapy, Manual therapy according to Van der Bijl and Orthomanual therapy are all forms of manual therapy. Osteopathy is according to the American Association Osteopathic (AOA) a manual medicine (Chila, 2011). In conclusion: osteopathy is not just a form of manual therapy, but a form of medicine. This has consequences for the thinking proces of the pediatric osteopath since medicine involves diagnostics, as stated above, in contrast to therapies which is only the application of techniques. This distuingishes (pediatric) Osteopathy from manual therapies that are implied in the death of the two children. Another distinction must be made between manual therapies and manual techniques. In the various therapy forms the same techniques may be used. Manual therapies include techniques to the joints, especially mobilization and manipulation techniques, the latter is often a High Velocity Low Amplitude technique ( HVLA) (Downie, 2010). Manual techniques are techniques such as the HVLA or the "folding technique”. As mentioned earlier, the "folding technique” as taught by the Upledger Institute, was used in two cases with serious adverse events in the Netherlands (Micha Holla, 2009). 1.1.3 Osteopathic philosophy Osteopathy is based on a philosophy which differs from regular medicine and has implications for the thinking process of the osteopath.The original philosphy is stated in the four basic principles of AT Still (1887), as recorded in Kirksville in 1954 (Chila, 2011): 1. The body is a unit; man is a unity of body, mind and soul. 2. The body is capable of self-regulating, self-healing and self-maintenance. 3. Structure and function are reciprocally dependent. 4. The osteopathic treatment is based on the understanding of the basic principles of unity of mind and body, self-regulation and the relationship between structure and function.

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Principle four is actually an addition so it can be stated that there are three basic principles. Examples of these principles in Osteopathic thinking today are: 1. The body is a unit is for Osteopaths as an example the relationship between for instance visceral mobility and the functioning of the musculoskeletal system (Liem, 2013). 2. Self-regulation means that the body is in a dynamic equilibrium, it seeks balance, but is never quite balanced. In the diagnosis of children, this is of importance because the dynamic aspect of development should be taken into account. As an example Piaget has already described illnesses that precede neurological development (Du Chazaud, 1998). 3. Structure and function are reciprocally dependent. This means that the functioning of an organ/ organ system/ human is always in conjunction with its structure. The structure is for Osteopaths an indication of what can be said about the function. These fields are the basis for the pediatric working Osteopath to support his thinking and diagnostics. This shows that the approach of the osteopath is more than an application of manual techniques as is done in manual therapies. Therefore adverse events should be seen in the light of the diagnostic capabilities and approaches of the mentioned treatment modalities. As Anthony Chila stated: “Osteopathy is about placing the right fulcrum at the right place and at the right time” (Chila, 2011). The three basic principles have been the basis for a framework which is developed by the Educational Counsil on Osteopathic Principles (ECOP) in 1984 (Chila, 2011). Here the following models are mentioned: 1. Biomechanical model 2. Circulatory (respiratory) model 3. Bioenergetic or metabolic model 4. Neurological model 5. Biopsychosocial model These models can be seen in the following current topics in Osteopathic Medicine: 1. Biomechanical model as in Fascia, because it is a structure / function that connects everything (systematic) and keeps us in balance (allostasis) (see Jahr Kongres OSD 2013 and the several Fascia congresses).

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2. Circulatory/ Respiratory model is a model of fluids with arteries/ veins/ lymphatic and liquor. Still spoke of this originally in his "arterial rule" (the artery rules the health of the tissue). These haemo- and lymfodynamic structures connect the parts of the body (systematic), ensure balance and health in the tissue (allostasis) and supply the nutrients for the assembly of structures. (see Jahr Kongres OSD 2014) 3. The bioenergetic or metabolic model which contains the Nutritional Endocrine Immunology (NEI) model. Wherein nutrients, hormones and the immune system provide allostasis, a communicative connection between the parts of the body (e.g., intestine and brain), and they express themselves in the development structures (Schedlowski, 1999). 4. Nervous System model, with Peripheral, Autonomous and Central parts. This is because these parts take care of the communication link, the conservation of allostasis (autonomic nervous system) and the formation of structure (see congres of Panta Rhei on the autonomic nervous system, 2014). 5. Body psychotherapy as for example according to Terence Dowling (OSD KO11), in which the interaction between environment, thinking and autonomous processes in the body cooperate/ communicate to ensure holism, to regulate (allostasis) and maintain dynamic balance during which they express themselves in structures (both physical and characterological). So physical development of the child coincides with its psychoemotional development. Because osteopathy contains these systems, a symptom such as a fixed cervical verterbrae is always seen in the context of these systems. As Still said: “ It is easy to find disease, but difficult to find health” (McKone, 2001). In summary, a philosophical and theoretical framework has been developed, there is enough knowledge about these areas and the integration of these fields is a part of osteopathic thinking. Here again we see the large difference between manual therapies which are focused on the musculoskeletal part of the body and osteopathy with its holistic approach. These models are partly already implemented in post graduate courses in Osteopathy (see OSD website). These areas are now briefly given in osteopathy training and are not yet at an accredited level. 1.2 Educational level of pediatric osteopaths in the Netherlands In analyzing the adverse events in this study, the background of the educational level of the osteopath is assessed. The hypothesis, if there is a relationship between

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educational level and adverse events, is also adressed in the results. This distinction is important for the quality in the treatment of children. Osteopathy in the Netherlands is not a form of mainstream healthcare but of complementary care. The discussion in the media after the two incidences was that these complementary forms of medicine should be prohibited to treat babies (Micha Holla, 2009). The comparison between educational training of professions such as pediatric physical therapist and pediatrician which are accepted forms of mainstream healthcare (source: bigregister.nl) and osteopathic training is given below. 1.2.1 Pediatric Physical Therapy (PT) (source: avansplus.nl/kinderfysiotherapie) Pediatric PT at a Masters level is 90 ECT (2520 study hours). The training consists for one part the development of scientific skills and the other part specialist competencies focused on diagnosing and treating children. Modules: 1. Master of professional practice 2. Measurement in the professional practice 3. Children with developmental delays 4. Child in infancy 5. Child in the first line of health care (optional module) and Child in rehabilitation (second line of health care) (optional module) In skills training and skills workshops, skills are trained in carefully observing, analyzing and measuring the motor skills of children. The capacity for clinical reasoning and choosing the appropriate treatment strategy is optimized. In social skills training consists of working on a proper attitude towards parents and children, even in difficult and complex situations. In parallel, there is knowledge and skill in developing evidencebased practice. 1.2.3 Pediatric Medicine (source: http://knmg.artsennet.nl/Opleiding-enherregistratie/RGS-1/Opleiding-kindergeneeskunde.htm) Training to become a pediatrician takes five years to follow after the basic medical training. It is a competency-based training. The research assistant (AIO) always starts at the university hospital. After one year, the AIO continues his training for twelve to eighteen months in one of the affiliated general hospitals in the region.

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The course consists of a basic block of four years. This includes the placement in the general hospital and a block of twelve months. Required courses include: neonatology, intensive care, outpatient and emergency room. Also, the required courses in different wards. The training consists of a universal part (common trunk) of four years and a differentiation stage in the last year. For the components of the common trunk of the following durations apply 1. Pediatrics in general hospital 12-24 months 2. Pediatrics in the academic center, 24-36 months, of which: 1. Neonatology 3-9 months 2. Intensive Care Pediatrics 3-9 months. (Neonatology and Intensive Care Pediatrics jointly nine to twelve months) Medicine (in contrast to therapy) takes a lot more time to study than osteopathy. One of the reasons is the requirement to be able to do the correct diagnosis.

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1.2.3 What is the level of paediatric osteopathy in the Netherlands? The basic training of an osteopath can be done in Netherlands after an education in physical therapy or medicine. The basic training is taught parttime in five years. The number of hours are different for each osteopathic school (International Academy for Osteopathy (IAO), College Sutherland (CS). More than half of osteopaths in the Netherlands (56.2 %) were trained by the IAO. College Sutherland a third (33.7 %). Most osteopaths (87.3 %) have done the part-time training after first having done physical therapy (88.7 %). (van Dun, 2013) Given here is a summary of the hours and subjects in the part time and full time courses, it involves the teacher dependent hours, not the teacher independent hours or self-study (sources: college-sutherland.nl, http://www.osteopathie.eu). Table 1.1 Overview of osteopathic training (PT=Part Time, FT=Full Time) CS PT

IAO PT

CS FT

Osteopathy Parietal

319

180

319

Osteopathy Visceral

209

135

209

Osteopathy Cranial

149

90

149

Philosophy and Concept

33

Embryology en Dissection

87

8

164

Biochemistry, Physics and Pathology

154

60

270

Labo, Pharmaco, Radio and nutrition

33

33

CAM

54

54

Neurology, First Aid and Pediatrics

44

23

77

290

157

580

Internship, Clinical integration Exams Methodology

Total

25

40

224

224

1620

ECTS (includes teacher independent)

164

14

40

653

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Adverse events in pediatric osteopathy

The teachers at the basic education are virtually all osteopaths without a scientific background (M.Sc, PhD.). Methodological knowledge is limited by the graduates in osteopathy and in continuing osteopathic education at Masters level, there is no accredited training by the Dutch Flemish Accreditation Board (NVAO). During basic training at most schools, no attention is paid to paediatric osteopathy. After basic osteopathy training there is a possibility to specialize in paediatric osteopathy. This is a follow-up study of two-years part-time, in which the following courses and hours are taught (each training has a different emphasis): General paediatric osteopathy, embryology, pregnancy, childbirth, newborn, neurological development, visceral problems, cardiovascular, cranium, immunology, endocrinology, Ear Nose Throat, opthalmology and orthodontics/ tempero mandibular joint. At Panta Rhei in the Netherlands fifteen modules are spread over two years (source: pro-osteo.com). Total number of training days is fifteen days in the first year and the second year seventeen days. This is totally 248 hours of teacher-dependent training. When we add here the number of teacher-independent hours (given the OSD standard this would be 1112), there is a total of 1360 hours which equates to 49 ECT. The master's program in Germany also includes a module methodology. The hours here are a total of 1800 hours of which 328 hours are teacher-dependent. The level of children's osteopathy in the Netherlands is lower than the training in Germany, given the number of hours of education 1360 compared to 1800) which is different. Comparing pediatric physical therapy with pediatric osteopathy, there is, in addition to the amount of hours (2520 compared to 1360 in the Netherlands), a difference in the application of skills which are trained more extensively. When compared to pediatric medicine the difference is great in the amount of hours (five full time years compared to two part time years) and in training basic medical knowledge. As to the inclusion of osteopathy, or pediatric osteopathy into mainstream healthcare, there is still the question about the amount of hours and the quality of the studies, when compared to regular medicine or physical therapy.

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1.2.4 Conclusion Chapter 1 The philosophical background, scientific knowledge and manual skills of the osteopath are essentially different than that of manual therapists. The advice is to help develop the scientific background of each osteopath in the future, to encourage more research by the osteopaths and to develop the habit of publishing the research. Until the ’90’s there were no RCT’s done. In chapter three it is shown that the amount of RCT’s is steadily improving each year. This is important for clinical decision making and prevention of adverse events in osteopathy. In chapter three the current efficacy studies in children’s osteopathy is reviewed. A definition is given of what is understood under side effects and adverse events.

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Chapter 2 Efficacy Studies and side effects The techniques that are currently used by osteopaths in general have been studied in the Benelux survey. (van Dun 2013). The majority of osteopaths (81.1 %) perform at each consultation again a diagnostic examination, of which 92.7 % is using exclusion diagnostics. (van Dun 2013). This seems important in the prevention of adverse events. The diagnostic techniques are inspection (3.82, this is on a four-point scale with four most used and never zero), palpation (3.66), examining visceral mobility (3.66), palpation of motion (3.60), Range of Motion (ROM 3.19) and fascia examination (3.05). The treatment techniques are visceral manipulation (3.1), and neuro viscero-cranial techniques (2.96), fascial techniques (2.78) , General Osteopathic treatment (GOT, 2.47), functional techniques (2.47) and the connective tissue techniques (2.36). About one-third of the respondants in the Benelux survey (34%) indicate that they use additional examination techniques: from physical therapy (18.9%) , Methode de Bakker (15.5%) , classical medical tests (8.9%), applied kinesiology (12.2%) or orthomolecular medicine (5.5%). Efficacy studies of techniques Manual techniques are techniques that are used in all kinds of professions. For example, a manipulation is used by, among others, chiropractors, manual therapists, osteopaths and orthomanual physicians. The technique is as a drug, in the right hands at the right time, applied with the proper intensity it can be effective. However, when used incorrectly it can be harmful. Opponents of Complementary and Alternative Medicine (CAM) see these incidents as mentioned before and than directly condemn the whole profession. This is similar to no longer prescribing the drug because someone has taken an overdose. In this chapter the efficacy studies are described that have been done into osteopathic treatment effects of specific complaints from children. This overview is given in the same manner as the previously discussed model of five. Thus fascial, fluidic, nutritional-endocrino-immunological, nervous and psychosociodynamic efficacy studies are described.

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2.1 Efficacy Studies What general effect studies have been done? The author conducted both a pubmed search and on swoo.nl, on the MESH terms osteopathy, pediatric osteopathy, osteopathy and children, and assessed the evidence. There is a systematic review done by Pozadski of the literature up until 2012. Only seventeen studies met the inclusion criteria. Of these, there were five randomized clinical trials of high methodological quality. Only one of the five showed a positive effect of Osteopathic Manipulative Treatment (OMT), the other four showed no visible effect. Repetition of the tests failed. Seven of the seventeen studies showed effects seen in eg asthma, colic and otitis media, but this was refuted in seven other studies. The final conclusion of the authors was that there is no evidence for the efficacy of OMT in pediatric pathology. Three randomized clinical trials showed no changes between the groups. (Posadzki, Lee et al. 2013) 2.1.1 Treatment bio-mechanical / fascial During pregnancy an osteopathic treatment is investigated by Nistler in 2010. She concluded that of the 78 women, 40 women who were randomized to the treatment group (three treatments between weeks twelve and sixteen), a short length of labor had, and relatively less complications. The pain experienced was less. (Gabriele Nistler 2010). In the first years of a child, according to Phillipi, it is better to speak of posture asymmetries and not flattened skull, KISS or predisposition posture. There are several studies on the effect of osteopathic treatment on the musculoskeletal system. They demonstrated that an osteopathic treatment in the first months of life significantly reduces the degree of asymmetry (Philippi H. 2006). Sergueef studied the medical data of 649 children in Lyon. Here she found a clear correlation between the observed stress patterns in the skull and the development of a positional plagiocephaly. The treatment should take place during the first three to four months as the skeleton has not yet been ossified. Positional and pregnancy plagiocephaly are the result of a chronic asymmetrical intrauterine position. Deformed plagiocephaly refers to forces that occur during pregnancy, childbirth and the first few

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months. Postural plagiocephaly is the result of an asymmetry in position. (Sergueef, Nelson et al. 2006). Rocchi has done a study in 2010 in four children to see the change in plagiocephaly after osteopathic treatments twice a week for three months. In these four children a reduction in the cranial asymmetry was seen (Rocchi and S. 2012). Lessard in 2011 examined the development of the cranial asymmetries in twelve children who each underwent four osteopathic treatments. There was a marked reduction in the cranial asymmetry, asymmetry of the skull base and trans-cranial asymmetry between the first and the third evaluation (Lessard, Gagnon et al. 2011). Lalauze - Pol described in 2009 that the treatments they do in Paris in children with abnormal cranial base lead to a lasting change in the cranial base and the dento fascial portion of the cranium. This must be done before the third year. She indicates that osteopathy has no place in the treatment of cranial synostosis, these are namely birth defects. It is only important for positional deformities (Lalauze-Pol, Fellus et al. 2009). Summary and Conclusion Phillipi, Rocchi and Lalauze - Pol showed that osteopathy is potentially useful in treating postural and head asymmetries. Currently there is a tendency in the cranial osteopathy to treat according to the biodynamic method (see post graduate courses). This soft approach, however, has not been studied on its effect on the neurological system or on the fascial system. If there really is posture and facial asymmetries, the fascial/ structural approach has been studied. The level of evidence however is still low. No RCT’s have been done. 2.1.2 Treatment of organ connective tissue The symptoms and treatment indication in organ function (whether or not tissue level) mainly relate to gastroesophageal reflux, breathing, feces and urine behavior in children. Rocchi has done a study in 2010 with four children to examine the change in Gastroesophageal Reflux Disease (GERD) after osteopathic treatments twice a week

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for three months. There was a decrease in the night-time waking and a decrease in the need to suck detected after feeding (Rocchi and S. 2012). Correa in 2011 a study on 38 adults with reflux, of which 22 adults received an osteopathic treatment and twelve received a sham treatment . The osteopathic treatment consisted of diaphragm techniques. He saw that there was an increase in the pressure of the lower esophageal sphincter compared to the sham where there was also a decrease in pressure of the sphincter. This indicates that a diaphragmatic treatment in children with reflux can possibly lead to reduced reflux because the low esophageal sphincter can function better (Rafael Correa 2011). However because the study was done on adults no conclusion can be drawn here. Tarsuslu has conducted a study on constipation in thirteen children with cerebral palsy. The design of the study is weak as he applied osteopathy to both treatment groups, the contrast factor was medication, one group does and the other does not receive medication. He concludes that Osteopathy seems sensible to use with constipation, although this conclusion is premature because the methodology of the study was weak (Tarsuslu, Bol et al. 2009). Nemett In 2008 did an investigation into the urinating behavior in 21 children aged between four and eleven years. These children were divided into three groups. The treatment group showed a greater improvement in the urinating and feces dysfunctional behavior. There was also a marked decrease in uretro-vesical reflux. (Nemett, Fivush et al. 2008) Guiney in 2005 examined the effects of osteopathy in asthma with children between four and eleven years old. Hundred Forty cases were studied, of which there are ninety in the osteopathic treatment group and fifty in a control group. He found a significant difference in peak expiratory flow values between the treatment and control group (Guiney, Chou et al. 2005). Hayden has studied 28 children prospectively in 2006 with abdominal cramps . They are treated for four weeks, once a week with cranial osteopathy. There was a marked decrease in crying between one week and four (C Hayden 2006 may). However the natural development of crying also shows a decrease with age.

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Pizzolorusso investigated in 2011, the length of hospital stay and gastrointestinal symptoms in 350 premature babies in a hospital in Rome. 162 children received osteopathic treatment. There was a significant difference in the admission time in the hospital, which was lower in the treated group than in the control group. There was also a decrease in gastrointestinal symptoms in the treated group (Pizzolorusso, Turi et al. 2011). Bramati has investigated 49 autistic children between three and eight years and treated them with Visceral Osteopathic Techniques (VOT) of the abdomen. After six treatments the effect was measured by eight questionnaires. Statistical analysis shows that vomiting and loss of appetite significantly reduced, and that there was also an improvement in eye contact. This case series was performed without a control group thus the validity is low (I. Bramati Castellarin 2010). Later she repeated this study in 26 children aged between three and eight years, another six treatments in six weeks and measured through eight questionnaires. Here it also showed that constipation and flatulence decreased (Castellarin, Drysdale et al. 2013). Regarding the assessment of functional gastrointestinal complaints, there is an investigation into the inter-rater reliability. It was found to be insufficient. The assessment of Functional Gastrointestinal Disorders (FGID) apparently is subjective and therefore unreliable (Austin, Henderson et al. 2013). Summary and Conclusion: Rocchi, Correa, Tarsaslu, Bramati and Hayden have investigated the influence of osteopathy in the digestive tract. There is an effect, although the power of the studies was low. In all these studies, the low number of participants, with little randomization so that the generalizability of the effects to other clients is low. The study of Bramati also showed another interesting effect as neurological development improves when the digestion improves. Pizzolorusso saw that osteopathic treatment of abdominal complaints leading to shorter hospitalization time. Here, too, the methodological quality of the study was low. Still, this is definitely a study that should be continued in neonates because the start of children is so important. Finally, we see in the study of Austin, that the assessment of the digestive problems between the various osteopaths is too differing.

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Adverse events in pediatric osteopathy

2.1.3 Bioenergetic or Metabolic treatment: otitis media In the distant past, osteopathy was often used in inflammatory pathology (McKone, 2001). The knowledge and skills of osteopaths (who were also doctor’s) was aimed at improving the state of the lymphatic system. This could be diagnosed and treated. Unfortunately, these techniques are nowadays only used by Chickly and Perrin (Chickly, 2001 and Perrin, 2007). In 2012, Morin investigated the relationship between the mobility of the temporal bone, which includes the ear canal, and the occurrence of middle ear infections. She has 64 children in a prospective cohort followed to examine this relationship. The researchers of otitis media were blinded to the mobility of the temporal bone that was found. It was found that an increased risk of otitis media was correlated with obvious limitations of the sutures of the temporal bone (Morin 2012). Steele has studied a research protocol in otitis media to see if there are adverse events that occurred in 2010. He came to the conclusion that this is not the case, and therefore is safe to carry out (Steele, Viola et al. 2010). Wahl in 2008 did a randomized placebo-controlled study, with a factorial design done in ninety children. There were four groups, which were the osteopathic group that received cranial OMT. Result was that there was no significant effect of cranial OMT on the decrease of Otitis Media (Wahl, Aldous et al. 2008). Degenhardt has treated eight children studied with repeated middle ear infection. Five of the eight children had no recurring inflammation after osteopathic treatments (Degenhardt B 1994). Summary and conclusion: The study of Wahl here is the most crucial here since it is the only methodologically sound one, and concluded that there is no effect of osteopathic treatment of middle ear infection. It is true that osteopathic treatment may be beneficial as prevention as Degenhardt indicates.

22

Adverse events in pediatric osteopathy

2.1.4 Review of neurological studies and Osteopathy Frymann has in three years treated 186 children between eighteen months and twelve years with or without neurological disorders. The effect of six to twelve Osteopathic Manual Treatment (OMT) was compared with an untreated group and it was found that neurological scores were significantly improved according to Houle 's Profile of Development (POD) (Frymann VM 1992 jun). The cranial treatment according to a CV4 technique gave in ten adults an increase in alpha brain waves as shown by a randomized crossover design study with a sham and a control group. Alpha brainwaves are in the development of the brains of interest, and are many times higher in children than in adults (Miana, Hugo do Vale Bastos et al. 2013). Kotzampaltiris in 2009 examined whether the cranial rhythm is different with crying babies than normal babies. He concluded that abnormal cranial rhythmic impulse (CRI), as assessed by blinded osteopaths, is found in children with excessive crying behavior (Kotzampaltris and al 2009 apr). Deslee has done a study in 2003 with five children with multiple disabilities, nine treatments according to biodynamic concept were done and evaluated on several factors. It indicates a change, however, there was too much bias in this study with a small number to make any conclusions (E. Deslee 2003). Duncan in 2008, compared cranial osteopathy and acupuncture with a control group for the treatment of children with cerebral pareses. Fifty-five patients were examined for eleven outcome variables. There was a statistically significant improvement in the mobility measurements and gross motor skills in children who underwent an osteopathic treatment compared to other therapies (B Duncan 2008 okt). It is also shown that a reduction in the heart rate variability, respiration rate and cognitive activity of the osteopath can have an inducing effect on the decrease of the activity of the autonomic nervous system of the patiënt. This would be able to create conditions for the improvement of sensorimotor skills such Frymann and Bramati already have shown. The latter is, of course, hypothetical.

23

Adverse events in pediatric osteopathy

Summary and Conclusions Since Kotzampaltiris has found a change in cranial rhythm with crying babies and a cranial treatment provides an increase in the alpha rhythm according Miana, we see indications, as Deslee has shown that treating the cranium can possibly have effects on the nervous system. However the quality of the studies was again too low, so further studies, preferably RCT’s need to be done. The mobility enhancement is demonstrated by Duncan. 2.2. Side effects or adverse events A side effect can be studied in relation to the techniques used (for example, after a manipulation), the objective treatment effect (the patiënt has more mobility), and finally the subjective treatment effect (the patiënt has less pain). 2.2.1 Description of side effects There are different degrees, according to Carnes, to classify side effects: 1. Serious (medium to long term, with unacceptable effects), 2. Mild (shorter and milder than severe) and 3. Light (non-serious) consequences, slightly negative effect light response and incident (Carnes, Mullinger et al. 2010). This classification was used in this study. 2.2.2 Influence on the assessment of side effects There are other aspects to the definition of adverse events, namely the quality of the treatment. Carnes describes four components which are connected to each other in order to determine the experience of the side effect (Carnes, Mullinger et al. 2010). The components are EPOC: Expectations of treatment Personal investment and responsibility Osteopathy encounter, the patiënt - physician relationship. Clinical changes or the effect after the treatment .

24

Adverse events in pediatric osteopathy

These EPOC components include the treatment experience and therefore also the perception of possible side effects. For example, Local pain / stiffness are the most frequently reported side effects by patients according to Carnes. The extent to which the patiënt experiences this has to do with the overall experience of the treatment. When all EPOC components are positive, the side effect will be experienced differently. Because of these factors in reporting adverse events, educational level of the parents and social impact of the complaints of the child have been included in the questionnaire of this adverse events study. 2.2.3 Environmental Factors Also, the clinical environment is a component which has an effect on the perceived quality of care. Other examples of a lack of quality were: lack of information, lack of respect, poor service, and other expectations. Thus, there are multiple factors that determine the outcome of the treatment. Another item to side effects is the delay of forwarding to the appropriate health care worker. Is the client denied proper treatment due to prolonged Osteopathy? This is included in our questionnaire by asking who they have been visiting, and whether they have visited a doctor for side effects. 2.2.4 Adverse events in manual techniques As already indicated in the introduction, there are techniques that are used by different disciplines. It is important to make a distinction of the techniques used, rather than only to the method of treatment used. Unfortunately there are very few effect studies on specific techniques. Vohra concluded that serious adverse events following treatment may be associated with pediatric spinal manipulation (Vohra, Johnston et al. 2007). In the Cochrane review of manual techniques with IBS it was concluded that spinal manipulation can not be labeled as safe (Dobson D 2012). Chiropractic spinal manipulation (HVLA technique), has been associated with serious side effects (Ernst 2007). The most common serious adverse events were due to vertebral artery dissections. Ernst suggests that we should rethink our policy regarding

25

Adverse events in pediatric osteopathy

the use of spinal manipulation. This is done in France in 2012, where manipulation of the spine to the cervical spine is prohibited. Side note here is that the high-speed rotation performed with plenty of power in a final position is the technique where most serious adverse events occur. Therefore, in future studies the technique used must be always indicated and must be specifically tested. 2.2.5 Adverse events in manual therapies 1.

In manual therapy. Half of the manual therapy patients experienced mild to

moderate side effects as defined by Carnes, after treatment (Carnes, Mars et al. 2010). 2.

In chiropractic. Miller found after looking at 5242 treatments that there was a

response to 749 chiropractic treatments, ranging from 24 hours after the treatment up to a required hospitalization. 80% of the parents reported an improvement of the symptoms. The actual amount of side effects, according to Miller, is one in 1300 treatments but Miller does not define what he assesses as a negative side effect (Miller and Benfield 2008). Cantara did a study in which he evaluated 5400 visit. The prevalence was two side effects per 1735 visits, which is one in 867, and not one in 1300 as Miller claimed (Alcantara, Ohm et al. 2009). Adverse reaction was not classified here as Carnes did, however, roughly speaking, the question was there a reaction of the treatment. 3.

In Osteopathy. Osteopathy differs from manual therapy and chiropractic in its

approach. For osteopaths a pariëtal lesion is seen as a symptom that can lead to a complete diagnosis, after each system (digestive, circulatory, etc.) has been examined (van den Heede, 2011). For instance, a higher position of the hyoid, possibly due to an umbilical cord wrapping around the neck at birth, can also lead to a cervical dysfunction. In Osteopathy a survey has been done among 502 pediatric patients data of which 346 met the inclusion criteria. No treatment-related complications (cerebro-vascular accidents, etc.) were reported. There were treatment-associated exacerbations in nine percent of the cases (Hayes and Bezilla 2006).

26

Adverse events in pediatric osteopathy

Conclusion There is no evidence for the effectiveness of manual therapy with regard to dysfunctions of the cervical vertebral column (E. Saedt 2010). All the above studies on adverse events have been done in adults. Therefore, one might conclude that in any event, manipulations do not belong in the treatment of children. 2.3 Who are the people using osteopathy? Although the majority of osteopaths confirms that the patiënt base consists mainly of adults (between 21 and 64 is 97%), all ages are represented. One third of the osteopaths (30.5%) indicated that the preferred group of patients to be treated in the practice, are infants (73.8%) and children (74.8%). The distribution of children by age in the Benelux survey was: less than 6 months, 49.7% , 6 months to 2 years 10%, 2 to 10 years 5.5% and 11 to 20 years 4.8% . Interestingly, the survey indicates that crybabies are relatively a frequent reason for visits to the osteopath in the Netherlands, and gastro-oesophageal reflux often in Flanders. Also seniority of the osteopath is a confounder for seeing more crybabies and gastro-oesophageal reflux. (van Dun 2013) Osteopathy is for insurers a part of Complementary and Alternative Medicine (CAM). CAM has been shown to be used by many children. In general, 54% of parents use CAM (Jean and Cyr 2007) with 71% being reported in Ottawa (Adams, Dagenais et al. 2013). In the Netherlands, Vlieger investigated CAM use, this shows that 40 % of children with their parents visit a CAM practitioner (Zuzak, Boňková et al. 2013). A recent study by the Central Buro for Statistics in the Netherlands (CBS) showed that osteopathy is in fourth place in the Netherlands in CAM use (after acupuncture, homeopathy and chiropractics) (Herten 2014). There is also a study conducted by ZonMW , which has shown that when CAM would be used instead of the doctor, the cost of the care that is applied can be reduced (ZonMW 2014). In Australia, 25% of the adults makes use of Osteopathy. CAM is there mostly for musculoskeletal disorders (27%) (Xue, Zhang et al. 2008). A note here is that users of CAM report a significantly lower satisfaction with primary care than non CAM users. This is a possible reason for going to use CAM. Most complaints about primary care concerned the inaccessibility and lack of information.

27

Adverse events in pediatric osteopathy

Most consumers consider CAM therapies as safe. This is believed by consumers but rarely questioned (Myers and Cheras 2004). Through whom’s referral do children visit osteopaths? Firstly, on the advice of another patiënt (2.9 on a scale of four with four being the most) than on the advice of a friend (2.8), on its own initiative (2.7), referral to a physiotherapist (1.6) then beware referral a doctor (1.3) (van Dun 2013). In 40% of the references , there is word of mouth from friends , family or previous experience by parents. Secondly, there is the reference by other CAM physicians (22 %) and thirdly by other CAM practitioners (17 %)(Xue, Zhang et al. 2008). With what kind of problems do children visit the osteopath? The first reason or cause why children come to an osteopath is due to fascial causes of the symptoms. These symptoms are often, flattened skull and preferred posture or postural asymmetry (see chapter 6). The second reason is of nutritional endocrine immunological of nature. There are cramps where the osteopath examines the intestinal disturbances in the flora and if the nutrition is of sufficient quality. This may also be factors in the spitting, as a significant portion of the patients also comes with symptoms of reflux, whether or not idle. Another factor is the middle ear, wherein afore mentioned immunological overload can be at the level of irritation of the gut or lung. The third reason is neurological in nature. Children show signs of restlessness, crying a lot, hyperextend, sleeping little, or in older children with ADHD, autism or developmental delay. Finally, there is the indication of biopsychosocial nature. The new relationship with the child brings along stress for many parents. Uncertainty about whether the child is OK, growing well, developing well, and so also reflects indeed the psychosocial status of the parents.

28

Adverse events in pediatric osteopathy

2.4 Survey of parents experience Earlier research on the experience of eight parents who showed up at an osteopathic treatment for their children by Gardner in 2011 showed that parents judge uncertainty and impatience of their child as not fitting and from there go find out what could be wrong. They come to osteopathy through previous experiences of friends and family . Trust and communication proved key to a positive outcome of the treatments. She cites earlier unpublished studies of Viedma-Dodd (2006) and Gibbons (2008) to the experience of mothers at the osteopath. In particular, the interpersonal reassuring character of the treatment is of importance here (Gardner 2011). 2.5 Rubenstein questionnaire The questionnaire that is used in this study is based on the questionnaire that was developed to examine the satisfaction of Chiropractic care (Ailliet, Rubinstein et al. 2010) (Rubenstein, 2006), which also includes detailed questions about the effects of treatment (see Appendix). Rubinstein based his questionnaire on several predictor variables that contribute to an outcome variable, in this case an "adverse event". The rate of adverse events can not be without involvement of the context or details of treatment. Therefore we have included this in our questionnaire. In the methodology chapter the changes that have been made in this questionnaire to translate it to the osteopathic situation are reported. Conclusion It can be seen that there are more and more efficacy studies in osteopathy. Especially after 2000, there is an increase. The ability to do a master of science and even philosophical doctorates in osteopathy reinforces this trend of more research. However, the quality of efficacy studies mentioned is still low. Usually the number of participants, the internal and external validity is too low. This will also be caused by the amount of professionals (700 osteopaths in the Netherlands), and the lack of budget to perform studies with more power and stronger methodology.

29

Adverse events in pediatric osteopathy

Chapter 3 Hypotheses The null hypothesis is that there are serious and mild adverse events in the osteopathic treatment of children. The alternative hypothesis is that there are light adverse events in a small number of treatments. The first goal of this study was to see who uses osteopathy for their children. How was the treatment perceived at forehand, but also afterwards. The goal was not to see if Osteopathy was effective, but to first get an impression of the satisfaction that parents had with the osteopathic visits. Most important in this result was if there were adverse events, and than what kind of adverse events, how many, how long did they last, etc. Is osteopathy safe? Another goal of the study was to see if there was any difference in the treatment satisfaction of the parents who visited an osteopath with no specific pediatric training as compared to the satisfaction when visiting an osteopath with pediatric training.

30

Adverse events in pediatric osteopathy

Chapter 4 Methods 4.1 Type of study It is a multi-center observational prospective cohort study on the occurence of adverse events of osteopathic treatments in children. This study is a pilot and will continu in 2015 in Norway and Sweden. 4.2 Participants: the osteopaths and the patients. 4.2.1 The osteopaths The invitation to join the study was send to 600 osteopaths. 59 responded with the intention to join. These people were contacted by Nielske Weggelaar, the pediatrician, to follow up and check if the procedure was clear and also to motivate them and suggest to them the importance to join this study. In the end there were 27 osteopaths who collected data. Of the respondents, 71 % were men. The Osteopaths filled in a digital form where they were asked about their training and experience. On average, they graduated in 2003 (SD, Mean) thus had 10 years of experience. and provides 50 % of the osteopaths continuing to have followed post graduate courses in osteopathy (pediatric Osteopathy followed by thirteen). It must be said that of the osteopaths who did not follow a specialized training in pediatric osteopathy, most followed post graduate small courses with a pediatric content. This indicates that the average osteopath has been treating children for 10 years. And a large part of the osteopaths are working full-time. 4.2.2 The patients; In -and Exclusion criteria In order to include as much children as possible, clients aged zero to fourteen years old were included. No patients were excluded because this was a survey and to have an accurate projection of the kind of children that visited the osteopath everybody was included. The parents were asked about the side effects of osteopathic treatment, and not the children. 4.3 Parameters The Rubenstein questionnaire was used as a basis because this was already validated and used in a prior study (Rubenstein, 2008). Some words in the questions were

31

Adverse events in pediatric osteopathy

changed, because of the words that were used, for instance chiropractor, and because the type of complaints that were cause to visit an osteopath are different for children. 4.4 Measurement Method : Questionnaire Osteopathy for Children Survey ( abbreviated VOKO in dutch or QOCS in English). The questionnaire was distributed by the Dutch Foundation Osteopathy (NVO) to private practices. 60 of the more than 700 osteopaths have registered of which 54 eventually started. As stated before, in the end only 27 sent in patient questionnaires. The study ran from November 2012 to June 2013 . The questionnaires were both in written form as well as a digital form ,which was placed on enquettemaken.be and mailed. There are nineteen osteopaths that used the paper version. These were handed to the parents before a treatment, and could be deposited, after filling it in, in a sealed box in the waiting area. The osteopath was blinded to the answers provided. The digital version was sent to 36 osteopaths. This was completed by the parents on a PC or Ipad before the treatments. Each Osteopath had his own number. In combination with the number of the patiënt, this leads to the following numbers : For example practice number is 13, client 02 is number 1302. In reviewing the data it already shows that not every therapist has followed this procedure. Due to the varying numbers, there is a number of data that has been lost. 4.5 Measurement personel Collecting data The filled in forms of the nineteen osteopathic practices that used the paper version were collected in a box in the waiting room. This so that the parents felt safe to answer freely because they saw that after filling in the form the osteopath could not look into them. When the box was full, and all the forms were filled in (we send each practice ten blanc forms for each visit, to promote the work of recruiting patients). The box was sealed and send to Amsterdam.

32

Adverse events in pediatric osteopathy

The secretary of Osteopathie Amsterdam than proceded to enter the paper form into the questionnaire that was online. This was done so that the summary of data could be gathered more easily. In the program enquetemaken.be it is easy to export the data into an Excel file which was the base for our data set. For the osteopaths all but two, filled in the online form. The two were later added to the digital data. Fig. 4.1 Flow chart of the procedure

Digital Form • Paper Form

Online collection

Excel

• Collect in Box

• Imported in digital questionnaire

4.6 Intervention The intervention was an osteopathic examination and treatment. 4.7 Procedure Data set workup After the data was collected in Excel files for each visit, the next step was to clean up the data set. To see if the missing data could be traced, and to see the missed input. Upon observing the data it was noticed that on the question of “with which complaints people visited the osteopath”, some filled in up to five complaints. The dataset was expanded to four extra columns for the first visit, so that all complaints could be filled in. After this was filled in, Arine Vlieger and Nielske Weggelaar as observers, performed a random survey of the data to see if the written questionnaires were filled in properly in the Excel file. The next step was to change the written text to categorical or numerical variables. The type of complaints were summarized and given a number (see table 5.7)

33

Adverse events in pediatric osteopathy

Table 4.7 Numerical classification of complaints Neurological

Code

Musculoskeletal

Code

Restlessness

10 Preferential position

20

Hyperextending

11 Does not lay on belly

21

Muscular tension

12 Plagiocephaly

22

Crying

13 Neck/ Back complaints

23

Sleeping problems

14 Hips/ Knees/ ankles/ feet

24

Headache

15 Collar bone

25

Tantrums

16

Tired

17

Stuttering/ Dyslexia

18

ADHD/ Gille de la Tourette

19

34

Adverse events in pediatric osteopathy

Table 4.7.b. Numerical classification of complaints Digestive system

Code

General

Code

Reflux/spitting/ burping

30 Check-up

40

Tummy ache

31 Eczema

41

Drinking/ Feeding problems

32 Ear-Nose-Throat complaints

42

Cramp

33 Airways/ lungs

43

Stool problems/ constipation

34 Bed wetting/ continence

44

Food intolerances

35 Weight problems

45

Table 4.8 Complaints Change variable How long

Last treatment

Change complaint after 1 treatment

complaint 1= Yes

1= < 1 week

1= yesterday

1= Completely gone

2 = No

2= 1-4 weeks

2= 2 days ago

2= A lot/ somewhat less

99 = Unknown

3= 1-3 months

3= 3 t/m 5 days ago

3= Slightly less

4= 4-11 months

4= 6 t/m 8 days ago

4= Unchanged

5= 1-3 years

5= 9 t/m 14 days ago

5= Slightly more

6= > 3 years

6= more than 14 days

6= A lot/ somewhat more

99= blanco

7= Unbearable 99=Blanco

35

Adverse events in pediatric osteopathy

Table 4.9 Side Effects Start side effect

Dissappear side effect

Severity Side effect

Cause behaviour change

1= Immediately after the

0= The same day

1= no side

1= vaccination

treatment (within 30 minutes)

effect

2= Later on the same day

1= not applicable

2=Light

2=Change of dieet

3= The day after the

2= the following day

3=Mild

3=Medication

3= 2-3 days later

4=Severe

4=Teething/ growth

treatment 4= 2 days after the treatment

spurt 5= >2 days after the

4= The side effect has

treatment

not dissappeared 99= don’t know

5=Sleeping ritual

6=Influenza/ otitis/ other inflammations 7=Motor development

4.8 Statistics 4.8.1. Data analysis The variables that were examined, were about the patiënt, the osteopath and treatment. 4.8.2 Type of Data The symptoms that may be associated with Adverse Events were measured on an 11 point NRS scale at the second, third and fourth visit. The outcome variables were dichotomized in patients with an adverse event compared with patients without an adverse event .

36

Adverse events in pediatric osteopathy

4.8.3 Type of statistical tests Univariate and multiple logistic regression analyzes (backward elimination, significance level P < 0.05) were used in order to identify possible predictors associated with specific osteopathic use. Cut-off points were defined by age (≤ 14 years), duration of symptoms ≤ 3 months), duration of treatment (≤ 3 months), side effects of allopathic medication ([very ]much), perceived effect of conventional therapy (little/ no effect ), health (fair/ poor, feelings of pain or discomfort ([very ] much), and absenteeism (> 5 days). The data are analyzed with R and with SPSS 21.0 ( SPSS , Chicago , IL , USA) . 4.9 Time schedule The development of the questionnaire started in spring 2012. The questionnaire was sent to the osteopaths in september of 2012. The forms were collected in June 2013. The work-up of the data took until summer 2014.

37

Adverse events in pediatric osteopathy

Chapter 5 Ethical aspects Because this was an observational study of a cohort, and not an randomized clinical trial, there was no need for an approvement of an ethics committee. Patients were not with-held treatments, since they had already applied for Osteopathy. The study was also judged by a committee in Sweden where it also will take place. It has been approved there also since it does not involve a study into an intervention, but into the satisfaction of treatments and the occurence of adverse events.

38

Adverse events in pediatric osteopathy

Chapter 6 Results The first questionnaire was filled in before the first visit. This was the data that is first presented. Following is the data that was collected before the second third en fourth visit, which represent the results of the first second en third treatment. This is presented collectively, beginning with the satisfaction of the treatment and than the side effects. The side effects are presented in amount, time they last, severity and relation to osteopath. 6.1 First Visit. N = 487 1. Gender: Boy (n = 261, 58 %) Girl (n = 193, 42 %), not filled in 33. 2. What age is your child?: From a total of 487 children, there were 294 aged between zero and three months. 98 between three months and a year. 25 between one and four years old, 41 older than four years and 29 whose parents did not fill in their age. Concluding: 80% of the children were younger than one year old. Value 1 0 t/m 3 mths 2 3mths - 1 year

# of Cases

%

Cumulative %

294

64.2

64.2

98

21.4

85.6

3 1-4 years

25

5.5

91.0

4 >4 years

41

9.0

100.0

Fig. 7.1 Age of the children (x-axis: age groups, y-axis: n) 3. What is the educational level of the mother and father? The person who fills out forms in 91 % of cases is the mother.

39

Adverse events in pediatric osteopathy

Of the 487 respondents, 10 % of mothers VMBO / Mavo done , 31 % Havo/ MBO , 41 % VWO/ HBO and 17 % University. For fathers (n = 458) is 13 % VMBO / Mavo , 34 % HAVO / MBO , 33 % VWO/ HBO and 18 % college or university. 4. Have there been visits to other caregivers? In 90 % of cases there was no previous visit to the osteopath, and only 26 % of the parents have been treated by osteopaths themselves. A finding was that 90 of the 487 respondents had not previously visited a doctor or a paramedic. It is indicated that there is an average of 1.63 ( on a scale of ten) of fear of the treatment, with a variance of 1.92.

Fig. 7.2 Fear of the treatment (x-axis: fear on 10 pt scale, y-axis: n) In earlier visits to other specialties, GP is indicated in 51 %, 32 % a pediatrician, 69 % a consultation desk doctor, a physiotherapist 23 % , and 13 % other therapists. No doctor seen : 90 , of which 8 have seen another therapist (8 Osteopaths).

Fig. 7.3 Earlier visits to other specialties (x-axis sort specialty, y-axis n)

40

Adverse events in pediatric osteopathy

Table 7.1 With which complaints are you visiting the osteopath? hinderklacht1_1 Frequency Valid

Valid Percent

0

2

,4

,4

,4

2

1

,2

,2

,7

105

21,6

23,3

23,9

Hyperextending

31

6,4

6,9

30,8

Muscle tension

11

2,3

2,4

33,3

Crying

75

15,4

16,6

49,9

Sleeping problems

48

9,9

10,6

60,5

Headache

8

1,6

1,8

62,3

Tantrums

2

,4

,4

62,7

Tired

1

,2

,2

63,0

Stuttering/ Dyslexia

1

,2

,2

63,2

ADHD/Gille de la Tourette

4

,8

,9

64,1

55

11,3

12,2

76,3

Plagiocephaly

2

,4

,4

76,7

Neck/ Back problems

8

1,6

1,8

78,5

Hip/ Knee/ Ankles/ Feet

3

,6

,7

79,2

Collar bone

4

,8

,9

80,0

Reflux/ Spitting/ Burping/ Hiccups

34

7,0

7,5

87,6

Belly ache

18

3,7

4,0

91,6

4

,8

,9

92,5

Cramp

13

2,7

2,9

95,3

Stool/ Obstipation

10

2,1

2,2

97,6

Check-up

1

,2

,2

97,8

Eczema

2

,4

,4

98,2

Ear Nose Throat complaints

3

,6

,7

98,9

Airway/ Lungs

2

,4

,4

99,3

Bedwetting

1

,2

,2

99,6

Vertigo

2

,4

,4

100,0

451 36 487

92,6 7,4 100,0

100,0

Restless

Preferential sleeping position

Drinking/ Feeding problems

Missing Total

Percent

Cumulative Percent

Total 99

41

Adverse events in pediatric osteopathy

6. Is there a relation between the age of the child and the type of complaint? The complaints which score highest were all related to children younger than one year old (80% of the patients): Hyperextending, Crying, sleeping problems, restlessnes, preferential position. 7. Medication Use When medication was used (n=99 , 20% used medication) 22 % claim to have side effects from the medication. 8. Number of days on sick leave 28 people had to miss up to two days of work because of the complaints of their child (6%). 9. How long the symptoms have existed The complaints exist less than one week (n=22, 5%), between one and four weeks (n=163, 36%), between one and three months (n=169, 37%), four and twelve months (n=54, 12%), one to three years (n=23, 5%) and more than three years (n=21, 5 %). Here we can see that most patiënts suffered between zero and three months. Because around 80% of the children are younger than one year it is logical that the complaints are mostly between one week and three months (n=354). 10. Severity of complaint When the amount of discomfort of the main complaint is on average 6.94, on a ten point scale, indicated by a variance of 6:44.

Fig. 7.4 Severity of complaint 1 (x-axis: severity 10 pt scale, y-axis: n)

42

Adverse events in pediatric osteopathy

In the second complaint is an average of 6.73 is indicated by a variance of 9.81

Fig. 7.5 Severity of complaint 2 (x-axis: severity 10 pt scale, y-axis: n)

11. Expectation of treatment The expectation of the outcome of treatment is on average 7:38 (on a scale of ten, with a good outcome being ten) with an SD of 5:33

Fig. 7.6 Expectation of the treatment (x-axis: positive expectation 10 pt scale, y-axis: n)

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Adverse events in pediatric osteopathy

6.2 Conclusion after the treatments 1. Satisfaction The mean of the satisfaction that was reported, was after the first treatment 8 (1st q= 7, 3rd q= 9). After the second treatment 7.8 (1stq=7, 3rd=9) and after the third treatment 8.3 (1stq=8, 3rdq=9). This leads to a satisfaction of the treatment of 8.

Fig. 7.7 Satisfaction after first treatment (x-axis: satisfaction 10 pt scale, y-axis: n)

Fig. 7.8 Satisfaction after second treatment (x-axis: satisfaction 10 pt scale, y-axis: n)

Fig. 7.9 Satisfaction after third treatment (x-axis: satisfaction 10 pt scale, y-axis: n) After the first treatment people reported that in 346 of the 351, they would visit an osteopath again. After the second treatment this was 212 out of the 216 and after the third 81 out of the 81. So as far as cliënt satisfaction, overall people are satisfied with the treatments and would visit an osteopath again.

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Adverse events in pediatric osteopathy

2. Side effects reported. People filled in their questionnaires before the visits. This means that when they filled the questionnaire in at visit two, they did so after the first visit. After the first visit (filled in before the second visit) (n=359) side effects reported were 46 (13%) and no side effects 313 (87%).

Fig. 7.10 Side effects after first treatment (x-axis: yes/ no side effects, y-axis: n) After the second visit (filled in before the third visit) (n=216) side effects reported were 29 (13%), no side effects 187 (87%) After the third visit (filled in before the fourth visit) (n=81) side effects reported were 10 (12,5%) and no side effects were 71 (87.5%) With the NoShow form (n=51) there were 7 side effects reported (14%). So the average value over the three treatment sessions is a total of 707 treatments, with 92 side effects reported. This results in an average of 13%.

Fig. 7.11 Amount of adverse events (x-axis: visit number, y-axis: n)

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Adverse events in pediatric osteopathy

3. Time the side effects lasted For the side effects (complaint 1 n=63, complaint 2 n=50) after the first visit this mostly lasted for not more than three days (1: n=36, 2: n=40) and did not go away in 9 cases. After the second visit (1: n=32, 2: n=27) this also lasted mostly not more than three days (1: n=21, 11 do not remember, 6 still had the side effect, 2: n=7, 4 do not remember, 4 still had the side effect). After the third visit (1: n=10, 2: n=5) this pattern also was there (1: n=5, 2: n=3, with both complaints there was one that did not go away).

Fig. 7.12 How long did side effects last (x-axis: visit number, y-axis: n) For the side effects that did not go away, it was checked if the side effect was the same as the original complaint. In some cases this was there. For instance if crying and sleeping problems were the complaints, this was often also noted as side effect of the treatment, which technically it is not.

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Adverse events in pediatric osteopathy

4. The side effect that were most reported and the relation to the complaint. The side effects that were reported mostly were crying, sleeping changes and restless.

Fig. 7.13 Crying side effect (x-axis: severity 10 pt scale, y-axis: n)

Fig. 7.14 Sleeping side effect (x-axis: severity 10 pt scale, y-axis: n)

Fig. 7.15 Restlessnes (x-axis: severity 10 pt scale, y-axis: n) There was no pattern between side effects in relation to a certain complaint. Light adverse event occur at 14% of the treatments. The length of the adverse event is around three days. The question arises whether the people who did not come and did not complete the No Show form, did not show up because of a positive treatment outcome or had negative experience.

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Adverse events in pediatric osteopathy

5. Side effects per Osteopath. Here there was not a clear pattern, other than that the more patients an osteopath saw the more side effects were reported. It appears that the percentages of 86% without side effects and 14% with side effects can be applies on the different osteopaths. 6. Side effects and experience Osteopath. Because in the end 27 Osteopaths worked with the forms, every one of them had experience with children and had done formal training or at least several short courses in children’s osteopathy. So there was no clear pattern to be distinguished between experience and complaints.

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Adverse events in pediatric osteopathy

Chapter 7 Discussion and Conclusion This study took around two and a half years to complete. The expectation on forehand was that around 3000 treatments would be a nice target and to be able to make statements about the amount and severity of the adverse events. A lot of time was put in the follow up of the osteopaths and to question and help them to collect the data. It became clear that most osteopaths are not used to doing research, as was pointed out in chapter one. In the end only twenty seven osteopaths out of the 700 registered osteopaths contributed. The osteopaths that registered could have created a selection bias, because they might be the ones that tend to do courses, invest in development, etc. In the future it would be nice to have more participants and reduce possible bias. A positive component of this study was that two pediatricians were part of the proces. The osteopaths were pleased about this cooperation. The connection between regular and complementary medicine was reinforced. These trends can already be seen for instance in the Children’s Center in Almere (kinderkliniek.nl) where regular pediatrics and osteopaths work together. Also in the article in the Journal for Pediatric Medicine in the Netherlands on the evidence in osteopathie from a pediatrician (Weggelaar, 2011). The collection of the data should have been done differently in hindsight. The changing of the filled in questions to numerical values so that statistics were possible, should have been done and thought about beforehand. It took a lot of time to redo the data, If done beforehand, this would have come immediately out of the digital questionnaire in a useable Excel file. There were two surprises in this study. One was that a relative large amount of people did not visit another caregiver before they visited the osteopath. This has direct consequenses for the ability to do regular diagnostics. The other surprise was that the age group that visits an osteopath is mostly younger than one year. In a study by Jong it was reported that 50% of the visitors to Complementary and Alternative Medicine, were younger than four years old (Jong, 2012). This has consequenses for the postnatal medical knowledge that is needed in diagnostics and treatment. Because the children are so young it is important to see if osteopathy is safe, which was shown in this population. The educational level of the parents was higher (60% ) than the average population (32%) (nationaalkompas.nl) in the Netherlands. This could have resulted in a bias because of more financial means and higher educated people tend to be more critical of what they experience.

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As for the results, the null hypothesis was that there are serious or mild adverse events in the osteopathic treatment of children. The alternative hypothesis is that there are light adverse events in a small number of treatments. The study showed that there are no serious or mild adverse events. Thus the null hypothesis can be rejected and the alternative hypothesis accepted. Light adverse events occur at 14% of the treatments. The length of this adverse event is around three days. From this sample it can be concluded that osteopathy is safe. The adverse events can be compared to the side effects that were reported as a result of medication use in this study, which was higher. Twenty percent of the patients used medication of which twenty-two percent reported side effects. In the study where the questionnaire was used by Rubenstein on the adverse events with adults after visiting a chiropractor, adverse events were reported in 56% of the cases (n=579). Of these reported adverse events 14% were mild. Their conclusion was that chiropractic treatment is safe (Rubenstein, 2008). The data of the Rubenstein study cannot be compared with the data presented here, because of the difference in age and type of complaints. Reporting of side effects was done by the parents. This could again introduce a bias. Parents reported an average expectation of the satisfaction of the treatments of 7.3. Therefore they expected a good result. Satisfaction after the treatments showed an even higher value of 8. In the future a blinded observer would give a less biased scoring on the adverse events. A suggestion for the type of study would be to compare an osteopathic treatment with a sham treatment and have a blinded observer score restlesness, crying, etc. The type of adverse events were mostly crying, sleeplesness and restlesness. These complaints can often be seen with children younger than one year old. Because this was the age group which was mostly seen, the question arises if these complaints were real side effects or can be related to other factors. These side effects were different than the original complaint and it was also reported that the side effects could be seen as a result of other factors such as vaccinations. For a future study the exact description of the side effects is needed to better evaluate the probable cause of the behaviour. As stated in Chapter one and two, osteopathy is a profession in development. The current state of affairs can be defined and there is still much work to do, before osteopathy has acquired a permanent place in the healthcare landscape in the Netherlands. There is however an upward trend in eduactional level and research.

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It has been elaborated what the remaining gaps in both education and efficacy studies are. Yet it should be stressed here that the basic principles of osteopathy provide an opportunity to take, within the domain of functional complaints in medicine, a firm place. The type of complaints as represented in table 7.1 can be defined as functional complaints (Hyman, 2006). Functional complaints according to the Free Dictionary (medical-dictionary.com) are: “interruptions in a patient's health, such as daily aches and pains, sleep disorders, digestive problems, fatigue, and mild depression, that can significantly affect the quality of life but have no organic cause”. The complaints as shown in table 7.1 also indicate that people visit osteopaths with complaints for which there are no medical diagnosis. These functional complaints are a field where the integration between osteopathic and regular care can increase. Because osteopaths are looking at the client from their basic principles: unity, health and growth, there are good opportunities for the future, since this is unique. Osteopathy has a different philosophical background and a different level of training than the regular therapies which were mentioned in the cases of the deceased babies. Further studies are needed to see if the high satisfaction that parents showed to have with osteopathy is also caused by the treatment results. And that these results that are obtained in treatments can be verified. The present study shows that osteopathy is safe within our sample. This will hopefully contribute more to the idea that Osteopathy is safe. Doctors and clients will demand in advance: "Is osteopathy safe with these patients?” This study will also therefore need to be expanded to effectiveness studies on the treatments, but also of the used diagnostic and treatment techniques. Still, there are enough indications that osteopathic treatment is beneficial as is shown in chapter two. When the amount of reported adverse events are taken into account, there is a trend that is also confirmed in our study. There is high satisfaction, moderate efficacy and few light adverse events. The results of this study in Norway and Sweden in 2015 will hopefully continue to contribute to the perception that osteopathy is a safe form of medicine. Whether it is also effective, will need to be further elaborated on in the future. There are already indications in that direction and, together with improving organization and communication between the different countries and research centers/ groups this can lead to a healthier profession.

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Chapter 8 Bibliography Adams, D., S. Dagenais, T. Clifford, L. Baydala, W. J. King, M. Hervas-Malo, D. Moher and S. Vohra (2013). "Complementary and Alternative Medicine Use by Pediatric Specialty Outpatients." PEDIATRICS. Advies, C. v. (2009). Beroepscompetentieprofiel Osteopathie. Ailliet, L., S. M. Rubinstein and H. C. W. de Vet (2010). "Characteristics of Chiropractors and their Patients in Belgium." Journal of Manipulative and Physiological Therapeutics 33(8): 618-625. Alcantara, J., J. Ohm and D. Kunz (2009). "The Safety and Effectiveness of Pediatric Chiropractic: A Survey of Chiropractors and Parents in a Practice-Based Research Network." EXPLORE: The Journal of Science and Healing 5(5): 290-295. Austin, P., S. Henderson, I. Power, M. Jirwe and T. Alander (2013). "An international Delphi study to assess the need for multiaxial criteria in diagnosis and management of functional gastrointestinal disorders." J Psychosom Res 75(2): 128-134. B Duncan, S. M.-M., K Worden, R Schnyer, J Andrews, FJ Meaney (2008 okt). Effectiveness of osteopathy in the cranial field and myofascial release versus acupuncture as complementary tratment for children with spasticcerebral palsy: a pilot study. J Am osteopath assoc. Kirksville, department of manipulative medicine. 108: 559-570. C Hayden, B. M. (2006 may). A preliminary assessment of the impact of cranial osteopathy for the releif of infantile colic. Complement ther clin pract. Gloucestershire, Churchdown osteopaths. 12: 251-257. Carnes, D., T. S. Mars, B. Mullinger, R. Froud and M. Underwood (2010). "Adverse events and manual therapy: A systematic review." Manual Therapy 15(4): 355-363. Carnes, D., B. Mullinger and M. Underwood (2010). "Defining adverse events in manual therapies: A modified Delphi consensus study." Manual Therapy 15(1): 2-6. Castellarin, I. B., I. Drysdale and V. Patel (2013). "Evaluation of behavioural and gastrointestinal symptoms in autistic children after visceral osteopathic treatment." International Journal of Osteopathic Medicine 16(1): e13-e14.

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Du Chazaud, J., (1998), Ces glandes qui nous gouvernent, Equilibre Chikly, B. (2001), “Silent Waves”, Upledger Inst; 1st edition Chila, A.G., (2011). “Foundations of Osteopathic Medicine.” Third edition. Wolters Kluwer, Philadelphia, USA: p.XV Degenhardt B, K. M. (1994). "Efficacy of osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media in children." JAOA 94(9): 673. Dobson D, L. P., Miller JJ, Vlieger AM, Prescott P, Lewith G (2012). "Manipulative therapies for infantile colic (Review)." The Cochrane Collaboration. E. Deslee, M. G. (2003). L’anxiété est elle un des freins majeurs au développement de la personne atteinte de trisomie 21? Downie, S.A, (2010), “Quantifying the high velocity, low amplitude spinal manipulation thrust: a Systematic Review.” Vol.33, Issue 7, p.542-553 E. Saedt, T. S., B. van der Woude (2010). "KISS in den Niederlanden – Aktueller Stand." Manuelle Therapie 14: 1-7. Ernst, E. (2007). "Adverse effects of spinal manipulation: a systematic review." JRSM 100(7): 330-338. Frymann VM, e. a. (1992 jun). "Effect of osteopathic medical management on neurologic development in children." JAOA 6: 729-744. Gabriele Nistler, U. D., Dorothea Lenz, Florian Schwerla (2010). "Osteopathy as a therapy during pregnancy: A randomised controlled trial." International Journal of Osteopathic Medicine 13(3): 128. Gardner, K. (2011). An exploration of the experience of parents in the osteopathic treatment of their infants. Guiney, P. A., R. Chou, A. Vianna and J. Lovenheim (2005). "Effects of Osteopathic Manipulative Treatment on Pediatric Patients With Asthma: A Randomized Controlled Trial." JAOA: Journal of the American Osteopathic Association 105(1): 7-12. Hawk, C., M. Schneider, R. J. Ferrance, E. Hewitt, M. Van Loon and L. Tanis (2009). "Best practices recommendations for chiropractic care for infants, children, and

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adolescents: results of a consensus process." J Manipulative Physiol Ther 32(8): 639647. Hayes, N. M. and T. A. Bezilla (2006). "Incidence of Iatrogenesis Associated With Osteopathic Manipulative Treatment of Pediatric Patients." JAOA: Journal of the American Osteopathic Association 106(10): 605-608. Herten, M. H.-v. (2014, 2014/04/20/06:29:32). "CBS - Bijna 1 miljoen mensen onder behandeling van een alternatieve genezer." from http://www.cbs.nl/nlNL/menu/themas/gezondheid-welzijn/publicaties/artikelen/archief/2014/2014-4041wm.htmfiles/278/2014-4041-wm.html. Heuschkel, R., N. Afzal, A. Wuerth, D. Zurakowski, A. Leichtner, K. Kemper, V. Tolia and A. Bousvaros (2002). "Complementary medicine use in children and young adults with inflammatory bowel disease." The American Journal of Gastroenterology 97(2): 382-388. Hyman, P.E. (2006). “Childhood Functional Gastrointestinal Disorders: Neonate/Toddler”. Gastroenterology 130:1519 –1526 I. Bramati Castellarin, F. H., VB Patel, IP Drysdale (2010). "Effect of osteopathic treatment on the gastrointestinal system function of autistic children." International Journal of Osteopathic Medicine 13(3): 120. Jean, D. and C. Cyr (2007). "Use of Complementary and Alternative Medicine in a General Pediatric Clinic." Pediatrics 120(1): e138-e141. Jong, M. (2012). “Integration of complementary and alternative medicine in primary care: What do patients want?. Pat Educ Couns. Volume 89, Issue 3, December 2012, Pages 417–422 Kotzampaltris, P. and e. al (2009 apr). The cranial rhythmic impulse and excessive crying of infants, J Altern complement med. Lalauze-Pol, R., P. Fellus, S. Lambert, M. Elmaleh and S. Bennaceur (2009). "L'analyse de la base du crâne dans les premières années de vie, une approche complémentaire du diagnostic et du traitement des classes II et III." Actualités OdontoStomatologiques (246): 179-189.

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Lessard, S., I. Gagnon and N. Trottier (2011). "Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants." Complement Ther Clin Pract 17(4): 193-198. Liem, T. (2013). “Leitfaden Viszerale Osteopathie”. Elsevier McKone, W.L. (2001). “Osteopathic Medicine. Philosophy, principles & practice.” Blackwell Science, Oxford, England: p.18 Miana, L., V. Hugo do Vale Bastos, S. Machado, O. Arias-Carrion, A. E. Nardi, L. Almeida, P. Ribeiro, D. Machado, H. King and J. G. Silva (2013). "Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: A qEEG pilot study." J Bodyw Mov Ther 17(3): 291-296. Micha Holla, M. M. I., A.M. (Ton) van der Vliet, Michael Edwards en Carin W.M. Verlaat (2009). "Overleden zuigeling na ‘craniosacrale’ manipulatie van hals en wervelkolom." NTvG 153: 1-4. Miller, J. E. and K. Benfield (2008). "Adverse Effects of Spinal Manipulative Therapy in Children Younger Than 3 Years: A Retrospective Study in a Chiropractic Teaching Clinic." Journal of Manipulative and Physiological Therapeutics 31(6): 419-423. Morin, C. (2012). "Suture restriction of the temporal bone as a risk factor for acute otitis media in children: cohort study." BMC Pediatrics 12(181). Myers, S. P. and P. A. Cheras (2004). "The other side of the coin: safety of complementary and alternative medicine." Medical Journal of Australia 181(4). Nemett, D. R., B. A. Fivush, R. Mathews, N. Camirand, M. A. Eldridge, K. Finney and A. C. Gerson (2008). "A randomized controlled trial of the effectiveness of osteopathybased manual physical therapy in treating pediatric dysfunctional voiding." J Pediatr Urol 4(2): 100-106. Perrin, R., (2007),”The Perrin techniques.” Hammersmith Press Limited Philippi H., F. A., Schleupen A., Pabst B., Jung T., Bieber I., Kaemmerer C., Dijs P., Reitter B. (2006). "Infantile postural asymmetry and osteopathic treatment: a randomized therapeutic trial, developmental Medicine and Child Neurology." 48: 5-9. Pizzolorusso, G., P. Turi, G. Barlafante, F. Cerritelli, C. Renzetti, V. Cozzolino, M. D'Orazio, P. Fusilli, F. Carinci and C. D'Incecco (2011). "Effect of osteopathic

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manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study." Chiropr Man Therap 19(1): 15. Posadzki, P., M. S. Lee and E. Ernst (2013). "Osteopathic Manipulative Treatment for Pediatric Conditions: A Systematic Review." Pediatrics 132(1): 140-152. Rafael Correa, C. u. C. S., Vanise D. Vecchia, Tomas Navarro-Rodriguez (2011). "Prospective Study of Osteopathic Manipulative Technique Increasing the Lower Esophageal Sphincter Pressure. Comparative Study With Control Group." GastroEnterology. Rocchi, M. R. and N. S. (2012). "The osteopath/pediatrician synergy for a non-invasive care of posistional plagiocephaly and gastroesophageal reflux in newborns: qualitative research and case studies." Rubenstein, S. et al, (2011). “Predictors of adverse events following chiropractic care for patients with neck pain”. Journal Manip Phys Ther. 31(2): 94-97 Schedlowski, M., (1999), Psychoneuroimmunology, Kluwer, p.581 Sergueef, N., K. E. Nelson and T. Glonek (2006). "Palpatory diagnosis of plagiocephaly." Complementary therapies in clinical practice 12(2): 101-110. Steele, K. M., J. Viola, E. Burns and J. E. Carreiro (2010). "Brief Report of a Clinical Trial on the Duration of Middle Ear Effusion in Young Children Using a Standardized Osteopathic Manipulative Medicine Protocol." JAOA: Journal of the American Osteopathic Association 110(5): 278-284. Tarsuslu, T., H. Bol, I. E. Simsek, I. E. Toylan and S. Cam (2009). "The effects of osteopathic treatment on constipation in children with cerebral palsy: a pilot study." journal of manipulative and physiological therapeutics 32(8): 648-653. van Dun, P. (2013). Status van de Osteopathie in de Benelux: Benelux Osteosurvey 2013. P. a. P. v. C. v. Commission for Osteopathic Research. Mechelen. Vohra, S., B. C. Johnston, K. Cramer and K. Humphreys (2007). "Adverse Events Associated With Pediatric Spinal Manipulation: A Systematic Review." Pediatrics 119(1): e275-e283.

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Wahl, R. A., M. B. Aldous, K. A. Worden and K. L. Grant (2008). "Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial." BMC Complement Altern Med 8: 56. Weggelaar, N. (2011). “Wanneer is `een duwtje in de rug' een slimme zet? Osteopathie en andere manuele therapieën bij kinderen”. Tijdschrift v. Kindergeneeskunde. 79(6):179-183 Xue, C. C. L., A. L. Zhang, V. Lin, R. Myers, B. Polus and D. F. Story (2008). "Acupuncture, chiropractic and osteopathy use in Australia: a national population survey." BMC Public Health 8(1). ZonMW (2014). Signalement Ontwikkeling en implementatie van evidence based complementaire zorg. Den Haag. Zuzak, T. J., J. Boňková, D. Careddu, M. Garami, A. Hadjipanayis, J. Jazbec, J. Merrick, J. Miller, C. Ozturk, I. A. L. Persson, G. Petrova, P. Saz Peiró, S. Schraub, A. P. Simões-Wüst, A. Steinsbekk, K. Stockert, A. Stoimenova, J. Styczynski, A. TzenovaSavova, S. Ventegodt, A. M. Vlieger and A. Längler (2013). "Use of complementary and alternative medicine by children in Europe: Published data and expert perspectives." Complementary Therapies in Medicine 21: S34-S47.

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Chapter 9 Appendix Patiënts Information letter Dear Sir / Madam, You have made an appointment for your child at an osteopath, perhaps due to complaints of excessive crying, spitting, pain or other complaints. The treatment that your child is going to get, usually already gives short-term relief of symptoms. It is known that an osteopathic treatment can sometimes give. Adverse reactions. Examples are a temporary worsening of the complaint, a feeling of stiffness or worse sleep. In most cases, these side effects are not serious and they pass pretty soon. Scientific research Our practice is working on a study of the reactions of children to osteopathic treatments. In the study we look at both positive and negative reactions. We also investigate what factors contribute to these reactions. This provides insight into which patients may or may not be eligible for consideration by the osteopath and helps in the future to deal better with children. There are about 50 osteopathic practices throughout the Netherlands who participated in this study. In total, over 1,000 patients are asked to cooperate. We also ask for your help to participate in this research. In this letter we give you information about the purpose of the examination, the examination to use and the advantages and disadvantages. Using this information you can decide whether you want to participate in the investigation. What does it mean for you and your child participate? If you participate in the study, this has no effect on the treatment that your child gets. The osteopath will give the same treatment as if you do not participate in the study. We ask you in the course of the investigation Up to 4 times to complete. a questionnaire The answers to the first questionnaire will take about 10 to 15 minutes to complete. During your second, third and (if necessary) fourth visit you will also get a questionnaire adapted to the change in the symptoms of your child and the responses he / she has received during or after treatment. Answering these questions will take about 10 minutes to complete.

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Side effects, risks, advantages and disadvantages The study consists only of completing questionnaires and poses no risk with it. You will not disadvantage or advantage of experience. Confidentiality of information The data in the context of this study collected about you will be treated confidentially. The data are entered on separate forms, which only a number relevant to the investigation is given, not your name and personal details. After completing the questionnaire you can do it in the attached envelope and seal it. The information about the research is so processed under a code. In publications you will not find your name retrieved. Voluntary participation You're completely free to participate in this study. Furthermore, you always have the right without giving any reason to refrain from further participation in the study. A decision to terminate your participation will have no adverse effect on your further treatment. Further information If after reading this letter, or even to receive further information during the study period, or are there any questions for you, you can always contact one of the members of the research team. On behalf of your osteopath and the research team, Sincerely, Dr. A.M. Vlieger, kinderarts en hoofdonderzoeker St Antonius Ziekenhuis Nieuwegein 030-6092071 Drs. N. Weggelaar, kinderarts Waterland Ziekenhuis Purmerend 0299-457457 Dhr. S. Kales, osteopaat Osteopathie Amsterdam 020-6201900

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Dr. M. Jong, onderzoeker Louis Bolk instituut Zeist 0343- 515611

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PATIËNT, first visit Needs to be filled in prior to the first treatment

If you please check the box that matches your answer. Please note, it is important that you answer all questions as completely possible. Your answers will remain anonymous. 1. Date…………………………………….. 2. Identification code ………………………………………………… If you please check the box that matches your answer. Please note, it is important that you answer all questions as completely as possible. Your answers will remain anonymous. Answers that are left blanco are scored as code 99 1) What's the sex of your child? boy (1)

girl (2)

1) What is the age of your child ………… years and ............ months 1. 0 till 3 months 2. > 3 months - < 1 year 3. 1 year till 4 years 4. 4 years and older 1) What is your relationship to the child? father (1)

mother (2)

caregiver (3)

remainder (4)

1) What is the highest level of education that the mother has completed? Lower Education (1)

HAVO, MBO (3)

VMBO, MAVO, LBO (2)

VWO, HBO

(4)

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University (5)

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1) What is the highest level of education that the father has completed? Lower Education (1)

HAVO, MBO (3)

VMBO, MAVO, LBO (2)

VWO, HBO

(4)

University (5)

1) For which complaints that your child has, do you visit the Osteopath? ……………………. …………………………………………………………………………………………………. For scoring of the complaints see the seperate list. 1) What were the two foremost complaints?......................................... …………………………………………………………………………………………………. For scoring of the complaints see the seperate list. 1)

On a scale of 1 till 10, how severe is complaint 1?

2) 1) On a scale from 0 till 10; how much does your child suffer from complaint 2?

1)

1)

How long does complaint 1 exist? 3 year (6)

How long does complaint 2 exist? 3 jaar (6)

14) Which of the following physicians/ practitioners did you vist with your child for these complaints?

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General Practitioner (a)

¨ yes ¨ no

Pediatrician (b)

¨ yes ¨ no

Consultational physician (c)

¨ yes ¨ no

Physical Therapist (d)

¨ yes ¨ no

Other therapists (e)

¨ yes ¨ no

1) In the case of visiting another therapist, could you fill in what kind of therapist? …………………………………………………………………………………………………….. 2) Does your child currentlly use medication? yes (1)

no (2)

1) In the case of yes: Does your child suffer from side effects? None (1)

few (2)

some (3)

a lot (4)

very much (5)

do not know

(6) 1) From which medication does your child suffer ffrom side effects? ................................................................................................................................. 19) How many days in the last month has your child missed daycare/ children’s care/ pre school/ school because of the complaints?…………………………………………………… 1)

How many days do you or your partner had to miss from work because of the complaints of your child? ............................................................

1)

Did you ever visit an Osteopath with your child before? yes (1)

no (2)

1)

If yes, when? ………………………..

1)

Did you or your partner visit an Osteopath before?

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yes (1)

no (2)

1)

How scared or afraid are you of the Osteopathic treatment for your child?

1)

How effective do you think the Osteopathic treatment will be?

Thank you very much for your cooperation!!

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PATIËNT, 2nd visit Needs to be filled in prior to the second treatment If you please check the box that matches your answer. Please note, it is important that you answer all questions as completely possible. Your answers will remain anonymous. 1. Date: ………………………………………………… 1. Identification code……………………………………. 1. When was your child’s last visit to the Osteopath?? Yesterday (1) 6 till 8 days ago (4)

2 days ago (2) 9 till 14 days ago (5)

3 till 5 days ago (3) more than 14 days

ago (6) 1. How bad was complaint 1 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10?

2. 1. How bad was complaint 2 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10?

2. 1. How bad were the complaints at the most during the past week on a scale of 0 tot 10?.

1. How is complaint 1 compaired to the period before your first visit to the Osteopath?

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Adverse events in pediatric osteopathy

Completely gone (1) A lot less (2) Somewhat less (3) Unchanged (4) Somewhat more (5) A lot more (6) Unbearable (7)

1. How is complaint 2 compaired to the period before your first visit to the Osteopath? Completely gone (1) A lot less (2) Somewhat less (3) Unchanged (4) Somewhat more (5) A lot more (6) Unbearable (7)

1. How satisfied are you up untill now about the treatment your child received by the Osteopath?

2. 1. Would you visit an Osteopath with your child in the future for these or other complaints? yes (1)

no (2)

2. Does your child have other complaints, side effects or adverse reactions since your first visit? no(2)

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Adverse events in pediatric osteopathy

yes (1) (Please continue with the next question on the following page)

(When you check this you are done with the Questionnaire) Thank you.

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Adverse events in pediatric osteopathy

1. The following table relates to other complaints, adverse events or reactions that your child has experienced since the first treatment. Which of the following has your child experienced and please give an estimate how much trouble he / she has (or had)? Complaint(s)

1.

Seriousness of the complaint

Are there other complaints please specify (see codelist) _______________________________________________________________

2. What were the two most annoying side effects? (see codelist) 1. _________________________________________________________

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Adverse events in pediatric osteopathy

2. _________________________________________________________ 1. When did side effect 1 start? immediately after the treatment (within 30 min.) (1) later on the same day (2) the day after the treatment (3) 2 days after the treatment (4) ………….. days later (please fill in) (5) don’t know or can’t remember (99)

1. When did side effect 2 start? immediately after the treatment (within 30 min.) (1) later on the same day (2) the day after the treatment (3) 2 days after the treatment (4) ………….. days later (please fill in) (5) don’t know or can’t remember (99) not applicable (99)

1. Is side effect 1 still there? yes (1)

no (2)

1. Is side effect 2 still there? yes (1)

no (2)

not applicable (99)

1. When did side effect 1 disappear? the same day as the side effect started (1)

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Adverse events in pediatric osteopathy

the next day (2) 2 to 3 days later (3) …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember (99) the side effect is still there (4)

1. When did side effect 2 disappear? the same day as the side effect started (1) the next day (2) 2 to 3 days later (3) …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember (99) the side effect is still there (4) not applicable (99)

1. In what way has side effect 1 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all (1) a bit (2) a lot (3)

1.

In what way has side effect 2 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all (1) a bit (2) a lot (3) not applicable (99)

1. Did you get in touch with the Osteopath in the period between treatments because of side effects/ reactions?

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Adverse events in pediatric osteopathy

yes (1)

no (2)

1. Did you visit a physician since you last visited the Osteopath? yes (1)

no (2)

1. When yes, what was the reason of your visit? (see score list)……………………………………………………………………………………………… 2. Have there occurred details, since the last visit to the osteopath, which may also have played a role in the before mentioned side effects / reactions? You can think of vaccinations, change of diet, infection and the like. (see score list) yes, (1) namely...............................................................................

Thank you for your cooperation!

71

no (2)

Adverse events in pediatric osteopathy

PATIËNT, 3rd visit Needs to be filled in prior to the third treatment If you please check the box that matches your answer. Please note, it is important that you answer all questions as completely possible. Your answers will remain anonymous. 1. Date: ………………………………………………… 1. Identification code……………………………………. 1. When was your child’s last visit to the Osteopath?? Yesterday (1) 6 till 8 days ago (4)

2 days ago (2) 9 till 14 days ago (5)

3 till 5 days ago (3) more than 14 days

ago (6) 1. How bad was complaint 1 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10?

2. 1. How bad was complaint 2 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10?

2. 1. How bad were the complaints at the most during the past week on a scale of 0 tot 10?.

1. How is complaint 1 compaired to the period before your first visit to the Osteopath?

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Adverse events in pediatric osteopathy

Completely gone (1) A lot less (2) Somewhat less (3) Unchanged (4) Somewhat more (5) A lot more (6) Unbearable (7)

1. How is complaint 2 compaired to the period before your first visit to the Osteopath? Completely gone (1) A lot less (2) Somewhat less (3) Unchanged (4) Somewhat more (5) A lot more (6) Unbearable (7)

1. How satisfied are you up untill now about the treatment your child received by the Osteopath?

2. 1. Would you visit an Osteopath with your child in the future for these or other complaints? yes (1)

no (2)

2. Does your child have other complaints, side effects or adverse reactions since your first visit?

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Adverse events in pediatric osteopathy

no(2)(When you check this you are done with the Questionnaire) Thank you. yes (1) (Please continue with the next question on the following page)

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1. The following table relates to other complaints, adverse events or reactions that your child has experienced since the first treatment. Which of the following has your child experienced and please give an estimate how much trouble he / she has (or had)? Complaint(s)

1.

Seriousness of the complaint

Are there other complaints please specify (see codelist) _______________________________________________________________

2. What were the two most annoying side effects? (see codelist) 1. _________________________________________________________

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Adverse events in pediatric osteopathy

2. _________________________________________________________ 1. When did side effect 1 start? immediately after the treatment (within 30 min.) (1) later on the same day (2) the day after the treatment (3) 2 days after the treatment (4) ………….. days later (please fill in) (5) don’t know or can’t remember (99)

1. When did side effect 2 start? immediately after the treatment (within 30 min.) (1) later on the same day (2) the day after the treatment (3) 2 days after the treatment (4) ………….. days later (please fill in) (5) don’t know or can’t remember (99) not applicable (99)

1. Is side effect 1 still there? yes (1)

no (2)

1. Is side effect 2 still there? yes (1)

no (2)

not applicable (99)

1. When did side effect 1 disappear? the same day as the side effect started (1)

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Adverse events in pediatric osteopathy

the next day (2) 2 to 3 days later (3) …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember (99) the side effect is still there (4)

1. When did side effect 1 disappear? the same day as the side effect started (1) the next day (2) 2 to 3 days later (3) …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember (99) the side effect is still there (4) not applicable (99)

1. In what way has side effect 1 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all (1) a bit (2) a lot (3)

1.

In what way has side effect 2 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all (1) a bit (2) a lot (3) not applicable (99)

1. Did you get in touch with the Osteopath in the period between treatments because of side effects/ reactions?

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Adverse events in pediatric osteopathy

yes (1)

no (2)

1. Did you visit a physician since you last visited the Osteopath? yes (1)

no (2)

1. When yes, what was the reason of your visit? (see score list)……………………………………………………………………………………………… 2. Have there occurred details, since the last visit to the osteopath, which may also have played a role in the before mentioned side effects / reactions? You can think of vaccinations, change of diet, infection and the like. (see score list) yes, (1) namely...............................................................................

Thank you for your cooperation!

78

no (2)

Adverse events in pediatric osteopathy

PATIËNT, 4th visit Needs to be filled in prior to the fourth visit. If you please check the box that matches your answer. Please note, it is important that you answer all questions as completely possible. Your answers will remain anonymous. 1.

1.)

Identificationcode……………………………………..

1.

2.)

Date: …………………………………………………

3. When was your child’s last visit to the Osteopath?? Yesterday

2 days ago

6 till 8 days ago

3 till 5 days ago

9 till 14 days ago

more than 14 days ago

4. How bad was complaint 1 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10? No

Unbearable

Complaints 0

1

2

3

4

5

6

7

8

9

10

5. How bad was complaint 2 for which you visited the Osteopath in the last 24 hours on a scale of 0 till 10? No

Unbearable

Complaints 0 1.

1

2

3

4

5

6

7

8

9

10

1. How bad was the complaint 1 at the most during the past week on a scale of 0 tot 10? No

Unbearable

Complaints 0 1.

2.

1

2

3

4

5

6

7

8

9

10

How bad was the complaint 2 at the most during the past week on a scale of 0 tot

10?

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Adverse events in pediatric osteopathy

No

Unbearable

Complaints 0

1

2

3

4

5

6

7

8

9

10

8. How is complaint 1 compared to the period before your first visit to the Osteopath? Completely gone A lot less Somewhat less Unchanged Somewhat more A lot more Unbearable 9. How is complaint 2 compared to the period before your first visit to the Osteopath? Completely gone A lot less Somewhat less Unchanged Somewhat more A lot more Unbearable 10. How satisfied are you up untill now about the treatment your child received by the Osteopath? Unsatisfied

Very satisfied 1

2

3

4

5

6

7

8

9

10

11. Would you visit an Osteopath with your child in the future for these or other complaints? yes

no

12. Does your child have other complaints, side effects radverse reactions since your first visit?

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Adverse events in pediatric osteopathy

no

(When you check this you are done with the Questionnaire)

Thank you. yes (Please continue with the next question on the following page)

13. The following table relates to other complaints, adverse events or reactions that your child has experienced since the first treatment. Which of the following has your child experienced and please give an estimate how much trouble he / she has (or had)?

little

unbearable

complaints 14. Are there other complaints please specify _______________________________________________________________ 15. What were the two most annoying side effects? 1. _________________________________________________________ 2. _________________________________________________________ 16. When did side effect 1 start? immediately after the treatment (within 30 min.) later on the same day the day after the treatment 2 days after the treatment ………….. days later (please fill in) don’t know or can’t remember 17. When did side effect 2 start? immediately after the treatment (within 30 min.) later on the same day the day after the treatment 2 days after the treatment ………….. days later (please fill in)

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Adverse events in pediatric osteopathy

don’t know or can’t remember not applicable 18. Is side effect 1 still there? yes

no

19. Is side effect 2 still there? yes

no

not applicable

20. When did side effect 1 disappear? the same day as the side effect started the next day 2 to 3 days later …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember the side effect is still there 21. When did side effect 2 disappear? the same day as the side effect started the next day 2 to 3 days later …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember the side effect is still there not applicable 22. In what way has side effect 1 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all a bit a lot 23. In what way has side effect 2 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all a bit a lot not applicable

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Adverse events in pediatric osteopathy

24. Did you get in touch with the Osteopath in the period between treatments because of side effects/ reactions? yes

no

25. Did you visit a physician since you last visited the Osteopath? yes

no

26. When yes, what was the reason of your visit? ........................................................................................................................................... .......

27. Have there occurred details, since the last visit to the osteopath, which may also have played a role in the before mentioned side effects / reactions? You can think of vaccinations, change of diet, infection and the like. yes, namely...............................................................................

no

This was the last questionnaire. When you have remarks, please note them on the space underneath. On behalf of the Osteopath and the research team, we would like to thank you for you cooperation and effort.

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Adverse events in pediatric osteopathy

No Show formulier Parents who unexpectedly did not appear or have called to cancel without creating a new appointment should be called .This involves the following questions:

1. 1.

What is the reason for cancelling?

•

•

There are no more complaints and further treatment is not necessary.

•

•

No effect up until now

•

•

Other reason: ……………………………..

……………………………………………………. 1. 2.

Have there been side effects in the last couple of days as a result of the

treatment? •

•

No

•

•

Yes, continu with question 3

3. Which side effects did you notice with your child? 1. 1.

………………………………………………………………………………….

2. 2.

………………………………………………………………………………….

4. When did side effect 1 start? immediately after the treatment (within 30 min.) later on the same day the day after the treatment 2 days after the treatment ………….. days later (please fill in) don’t know or can’t remember 5. When did side effect 2 start? immediately after the treatment (within 30 min.) later on the same day the day after the treatment 2 days after the treatment ………….. days later (please fill in) don’t know or can’t remember not applicable

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Adverse events in pediatric osteopathy

6. Is side effect 1 still there? yes

no

7. Is side effect 2 still there? yes

no

not applicable

8. When did side effect 1 disappear? the same day as the side effect started the next day 2 to 3 days later …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember the side effect is still there 9. When did side effect 2 disappear? the same day as the side effect started the next day 2 to 3 days later …….…….…….. days after the development of the side effect (please fill in) I don’t know or i can’t remember the side effect is still there not applicable 10. In what way has side effect 1 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all a bit a lot 11. In what way has side effect 2 or the inconvenience influenced the normal daily activities at home or at the daycare/ school? not at all a bit a lot not applicable

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Adverse events in pediatric osteopathy

12. Did you get in touch with the Osteopath in the period between treatments because of side effects/ reactions? yes

no

13. Did you visit a physician since you last visited the Osteopath? yes

no

14. When yes, what was the reason of your visit? ........................................................................................................................................... ....

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