National Medical Policy

National Medical Policy Subject: Mechanical Stretching Devices for Joint Stiffness and Contracture Policy Number: NMP277 Effective Date*: September ...
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National Medical Policy Subject:

Mechanical Stretching Devices for Joint Stiffness and Contracture

Policy Number: NMP277 Effective Date*: September 2006 Updated :

April 2016

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State’s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

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Reference/Website Link

X

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Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)



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If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers dynamic splinting / low-load prolonged-duration stretch device (e.g. Dynasplint) for the knee, elbow, wrist or finger medically necessary for either of the following indications: 1. As an adjunct to physical therapy in patients with symptoms of significant joint motion stiffness unresponsive to other therapies in the sub-acute injury or postoperative period (i.e., at least 3 weeks after injury or surgery but no more than 4 months after injury or surgery) 2. In the acute post-operative period for patients who are undergoing additional surgery to improve motion of a previously affected joint. Not Medically Necessary Health Net, Inc. considers all of the following not medically necessary due to a paucity of current ongoing published peer reviewed evidence supporting their efficacy: 1.

Dynamic splinting devices in the management of joint injuries of the shoulder, or any other joint not noted above; and

2.

Dynamic splinting devices are for use in the management of chronic joint stiffness and/or chronic or fixed contractures; and

3.

Static Progressive Stretch (SPS) devices and Patient-actuated serial stretch (PASS) devices, for all indications, (eg., finger extensor injury, etc.); and

4.

Jaw dynasplint device for the treatment of TMJ or trismus.

Investigational Health Net, Inc. considers the Intrepid Dynamic Exoskeletal Orthosis (IDEO) investigational since it is not FDA approved at this time.

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9 Codes

(May not be all inclusive) 718.43 Contracture of joint, forearm 718.44 Contracture of joint, hand 718.48 Contracture of joint, other specified sites 719.53 Stiffness of joint, forearm 719.54 Stiffness of joint, hand

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719.58 905.2 905.3 905.8 906.6 906.7 906.8 V54.10 - V54.16

Stiffness of joint, not elsewhere classified Late effects of fracture of upper extremities Late effects of fracture of lower extremities Late effects of tendon injury Late effects of burn of wrist and hand Late effects of burn of other extremities Late effects of burn of other specified site Orthopedic aftercare for healing traumatic fractures

ICD-10 Codes M24.50 M24.511-M24.519 M24.521-M24.529 M24.531-M24.539 M24.541-M24.549 M24.551-M24.559 M24.561-M24.569 M24. 571-M24.576 M25.60 M25.611-M25.619 M25.621-M25.629 M25.631-M25.639 M25.641-M25.649 M25.651-M25.659 M25.661-M25.669 M25.671-M25.676 S32.401DS32.499D S42.001AS42.496A-S S42.2Ø9SS42.4Ø9S S42.9ØXS S42.101DS42.199D S42.201DS42.496D

S42.9ØXDS42.92XD S49.ØØ1DS49.199D S52.9ØXS-

Contracture, unspecified joint Contracture, shoulder Contracture, elbow Contracture, wrist Contracture, hand Contracture, hip Contracture, knee Contracture, ankle and foot Stiffness of joint, not elsewhere classified Stiffness of shoulder, not elsewhere classified Stiffness of elbow, not elsewhere classified Stiffness of wrist, not elsewhere classified Stiffness of hand, not elsewhere classified Stiffness of hip, not elsewhere classified Stiffness of knee, not elsewhere classified Stiffness of ankle and foot, not elsewhere classified Fracture of acetabulum Fracture of shoulder and upper arm Unspecified fracture of upper end of unspecified humerus, shaft of humerus, unspecified arm, or lower end of unspecified humerus, sequale Fracture of unspecified shoulder girdle, part unspecified, sequela Fracture of scapula, unspecified, displaced, nondisplaced, subsequent encounter for fracture with routine healing Unspecified fracture of humerus, upper end of right, left arm or unspecified; surgical neck of right, left, or unspecified arm; displaced, nondisplaced; shaft, right, left, greenstick, transverse, oblique, dorsal, comminuted, segmental; lower end, simple supracondylar, without intercondylar fracture; lateral epicondylar, avulsion of medial epicondyle; lateral, medial, or transcondyler fracture; Torus fracture of lower end, of right, left or unspecified arm; Other fracture of lower end of humerus Fracture of shoulder girdle Other and unspecified injuries of shoulder and upper arm

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S62.90XS S52.ØØ1DS52.Ø99E S52.1Ø1DS52.2Ø1D S52.2Ø2DS52.299D S52.3Ø1DS52.399D S52.5Ø1DS52.599D S52.6Ø1DS52.699D S52.9ØXD S52.9ØXE S52.91XDS52.92X S59.ØØ1S59-002 S59.ØØ9D S59.Ø11DS59.Ø99D S59.1Ø1DS59.299D S62.ØØ1DS62.399D S62.5Ø1DS62.526D S62.6ØØDS62.669D S62.9ØXDS62.92XD S82.ØØ1DS82.Ø99D S82.1Ø1DS82.199DS82.399D S82.4Ø1DS82.839E S82.841DS82.846E S82.851DS82.856E S82.9ØXD-

Unspecified fracture of unspecified forearm or wrist and hand, sequale Fracture of upper end of ulna Fracture of upper end of radius Fracture of shaft of ulna Fracture of shaft of radius Fracture of lower end of radius Fracture of lower end of ulna Unspecified fracture of unspecified forearm, subsequent encounter for closed fracture with routine healing Unspecified fracture of unspecified forearm, subsequent encounter for open fracture type I or II with routine healing Unspecified fracture of right or left forearm, subsequent encounter for closed fracture with routine healing Unspecified physeal fracture of lower end of ulna, right arm, or left arm, subsequent encounter for fracture with routine healing Unspecified physeal fracture of lower end of ulna, unspecified arm, subsequent encounter for fracture with routine healing Salter Harris fractures, and other physeal fractures of lower end of ulna Physeal fracture of lower end of radius, unspecified or SalterHarris Type I-IV Fracture at wrist or hand level Fracture of thumb Fracture of other and unspecified fingers Unspecified fracture of unspecified or right and left wrist and hand, subsequent encounter for fracture with routine healing Fracture of patella Fracture of tibia Fracture of fibula Bimalleolar fracture of lower leg Trimalleolar fracture of lower leg

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S82.9ØXF

Unspecified fracture of unspecified lower leg, subsequent encounter for closed or open fracture with routine healing

CPT Codes 29126 29131

Application of short arm splint (forearm to hand); dynamic Application of finger splint, dynamic

HCPCS Codes E1800 E1801 E1802 E1805 E1806 E1810 E1811 E1812 E1815 E1816 E1818 E1820 E1821 E1825 E1830 E1831 E1840 E1841

Dynamic adjustable elbow extension/flexion device, includes soft interface material Bi-directional static progressive stretch elbow device with range of motion adjustment, includes cuffs Dynamic adjustable forearm pronation/flexion device, includes soft interface material Dynamic adjustable wrist extension/flexion device, includes soft interface material Bi-directional static progressive stretch wrist device with range of motion adjustment, includes cuffs Dynamic adjustable knee extension/flexion device, includes soft interface material Bi-directional static progressive stretch knee device with range of motion adjustments, includes cuffs Dynamic Knee, extension/flexion device with active resistance control Dynamic adjustable ankle extension/flexion includes soft interface material Bi-directional static progressive stretch ankle device with range of motion adjustment, includes cuffs Bi-directional static progressive stretch forearm pronation/supination device with range of motion adjustment, includes cuffs Replacement soft interface material, dynamic adjustable extension/flexion device Replacement soft interface material/cuffs for bi-directional static progressive stretch device Dynamic adjustable finger flexion/abduction/rotation device, includes soft interface material Dynamic adjustable toe extension/flexion device, includes soft interface material Static progressive toe device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories Dynamic adjustable shoulder extension/flexion device, includes soft interface material Multi-directional static progressive stretch shoulder device, with range of motion adjustability, includes cuffs

Scientific Rationale – Update April 2015 Intrepid Dynamic Exoskeletal Orthosis (IDEO) was developed by the U.S. Army and is a customizable energy-storing device that is designed to support and protect an extensive array of lower extremity limb injuries. TechLink assists the U.S. Department of Defense in licensing its inventions to industry, enabling companies to

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create new products and services. The IDEO was designed by prosthetist Ryan Blanck at the Center for the Intrepid (CFI). It is a custom-fit device made from carbon and fiberglass that supports the foot and ankle and resembles an amputee’s running prosthetic. At this time, the IDEO is not FDA approved. Per the website, IDEO has quantified advantages over existing braces and orthoses in terms of patient comfort and performance. The device supplies energy storage and return capabilities that an injured ankle is no longer able to provide. The IDEO returns considerable functionality to patients that have undergone ankle fusion procedures and even enables many patients with nerve and muscle loss to forgo ankle fusion or tendon transfer. The IDEO device is modular throughout the rehabilitation period to adapt to a patient’s changes in strength and motion. Once the patient has progressed to an adequate level of recovery, the initial modular IDEO is replaced with a lighter, more dynamic definitive IDEO system that has enabled wounded soldiers to return to duty. There is a Clinical Trial, 'PRIORITI-MTF Study- Testing Patient Response to the IDEO' that is currently recruiting participants. The ClinicalTrials.gov Identifier is NCT02158884, and it was last updated November 10, 21014. The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle. The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed). The estimated primary completion date is December 2015. There is a paucity of peer reviewed published literature on this device. The majority of the information was from TechLink or the armed services. IDEO is not FDA approved at this time, and it is considered investigational.

Scientific Rationale – Update November 2014 There are no ongoing Clinical Trials on dynasplint for the shoulder. Many of the ongoing clinical trials on dynamic splinting have been terminated. Per Sokolove et al. (2013, MD Consult) Proper care after diagnosis and repair of an extensor tendon injury is extremely important for optimal patient outcome. Even the best initial tendon repair can have a poor result if subsequently treated improperly. Rehabilitation of tendon injuries has evolved since 1980 to include dynamic splinting and active range-of-motion exercises to achieve maximal motion of the affected digit. Dynamic splinting with active motion is added at 3 to 4 weeks, and resistance is added at 7 weeks. A randomized, controlled trial of zone 5 and 6 extensor tendon repairs found total active motion with dynamic splinting to be superior to static splinting at 4 to 8 weeks, but not at 6 months. NICE has no information on dynamic splinting.

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Scientific Rationale – Update July 2013 Dynamic splinting is commonly used in the post-operative period for the prevention or treatment of motion stiffness/loss in the knee, elbow, wrist or finger. It is not generally used in other joints such as the hip, ankle or foot. Jongs et al. (2012) Completed a randomized, rater-blinded, controlled trial enrolling 40 patients with wrist contractures due to distal fracture of the radius. For 8 weeks, the LLPS group received LLPS and underwent the same standard rehabilitation program (consisting of general advice and a monitored, but unsupervised, home exercise program) as the control group. Primary outcome measures were primary wrist extension and Patient-Rated Hand Wrist Evaluation (PRHWE); secondary outcomes were active wrist extension, flexion, radial and ulnar deviation, and the Canadian Occupational Performance Measure instrument (performance and patient satisfaction items). The outcomes were assessed at 8 weeks and at 12 weeks. There was a small treatment effect at 12 weeks for passive wrist extension. The mean difference in passive wrist extension was 4° (95% confidence interval [CI], –4 to 12) at 8 weeks and 6° (95% CI, 1 to 12) at 12 weeks. However, there was no difference in PRHWE at 8 weeks (–2 points; 95% CI, –8 to 4) and at 12 weeks (2 points; 95% CI, –5 to 9), and no statistical difference in any of the secondary outcomes. This suggests that LLPS does not provide therapeutic benefits. The LLPS duration varied considerably among patients and could have confounded the results. However, the study represents real-life conditions and therefore reflects effectiveness in a general clinical practice setting. Doucet et al. (2012) examined the use of the 'Wrist Extension Dynasplint System' in patients who had sustained a stroke at least one year earlier. These patients experienced wrist flexion contracture, increased tone, and were not actively enrolled in skilled therapy. Wearing time of the Wrist Dynasplint System was 4 hours, 4 times per week, which is less than half Dynasplint Systems protocol for recommended wear time. Even with considerably less than optimal wear time, participants demonstrated increased wrist extension range of motion and decreased tone. The intervention continued for 12 weeks. After discontinuing the Dynasplint System, some participants regressed in range of motion. This paper supports long term use of Dynasplint Systems in the chronic, neurologically impaired patient for nonpharmacological tone control and range of motion progression. John et al. (2011) completed a randomized controlled study on 50 patients (aged 29 to 69 years) diagnosed with post-operative hallux limitus (HL), a pathology of degenerative arthritis in the first metatarsophalangeal joint (MTJ) of the great toe. This onset commonly occurs after, a bunionectomy or a cheilectomy surgery. The duration of this study was 8 weeks, and all patients received non-steroidal antiinflammatory drugs, orthotics, and instructions for a home exercise program. Group ONE of patients were also treated with dynamic splinting for first MTJ extension (60 minutes, 3 times per day). The dependent variable was change in active ROM (AROM). A repeated measures analysis of variance was used with independent variables of patient categories, surgical procedure (cheilectomy versus bunionectomy) and duration since surgery. There was a significant difference in change of AROM for Group ONE versus control patients (p < 0.001, T = 4.224, n = 48); there was also a significant difference for patient treated within 2 months of surgery (p = 0.0221). The authors concluded that dynamic splinting was effective in reducing contracture of post-operative hallux limitus in this study; Group ONE patients gained a mean 250% improvement in AROM. The authors state that this modality should be considered for standard of care in treating post-operative hallux

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limitus. However, this study was small based on 50 participants and the duration was only an 8 week period. Long-term outcomes would be necessary to determine the safety and efficacy of dynamic splinting for individuals with post-operative hallux limitus (HL). Baranano et al. (2011) conducted a retrospective chart review of patients who had undergone Dynasplint Trismus System (DTS) therapy during a 1-year period. Our inclusion criteria were cancer of the upper aerodigestive tract; treatment with radiation, chemotherapy, and/or surgery; and a maximal incisal opening (MIO) of less than 30 mm. MIO and the rate of improvement of trismus ("gain") were measured at selected intervals. Twenty-six patients met our study criteria; their pretherapy mean MIO was 19.3 mm. At the time of their most recent measurement, the mean MIO had increased to 25.5 mm-a measured gain of 32%. Although the initial rate of gain was 0.36 mm/day during the first 6 weeks, improvement leveled off over time, and the overall rate of gain was 0.16 mm/day. Curran et al. (2011) completed a case series on 18 patients (mean age 46, range 29 – 65 years, 9 females, 9 males) with a prior history of medial malleolar fracture, surgical fixation and contracture of more than one year took part. Dynamic splinting was prescribed for wear each night, achieving 6 to 8 hours of passive end-range stretching. The tension of the Dynasplint was changed twice a month to optimize the stretch at end range of motion. The mean duration was 16 weeks (range 12-22 weeks) and the patients mean wear was 784 hours (range 660 – 960) in end-range therapy from dynamic splinting. Maximal dorsiflexion was measured at baseline (enrolment) and at four months. The mean maximal change in dorsiflexion was 23.4º (SD=14.1). Contracture reduction is thought to require comparable amounts of time equaling the duration of contracture development. Low force, prolonged, passive stretching is considered to have the most beneficial effect in contracture reduction due to its ability to facilitate permanent changes in connective tissue elongation. The 60% change in maximal dorsiflexion noted in this study can be directly related to the duration of treatment as home therapy. A larger controlled trial should be conducted to measure empirical efficacy of dynamic splinting for contracture reduction following malleolar fractures. Berner et al. (2010) completed a retrospective case series of 133 patients, evaluated LLPS to treat wrist contractures due to distal radius fracture. The patients initially wore the splint for 4 to 6 hours, which was gradually increased to 6 to 8 hours per day. Outcome measures were the change in active wrist ROM. There were significant improvements in mean ROM for all patients, and the mean increase in wrist extension was 16° ± 2.1°. This result suggests that LLPS may improve active wrist ROM following distal radius fracture. However, several factors reduced the quality of this study, including retrospective design, lack of a control or comparator group, lack of follow-up, and involvement of the manufacturer in the study, thus precluding definitive conclusions. There is an interventional Clinical Trial on 'Dynasplint for Distal Radius Fracture', that is not yet open for participant recruitment. The ClinicalTrial.gov. identifier is NCT01032356, and it was last updated on April 27, 2012. The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures. The estimated primary completion date is June 2016. The estimated enrollment is 50 participants. The sponsor for this study is Dynasplint Systems.

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There is another Clinical Trial on 'Wrist Extension Dynasplint (WED) Distal Radius Fracture' which is also not yet open for participant recruitment. The ClinicalTrials.gov. Identifier is NCT01589627, and it was last updated on April 30, 2012. The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture. This is an interventional, randomized study with the estimated enrollment of 50 participants and the estimated primary completion date of December 2016. The sponsor for this study is also Dynasplint Systems. An interventional, randomized, Clinical Trial on 'Ankle Equinus Contracture Treated With Dynamic Splinting', is currently recruiting participants. The ClinicalTrials.gov. Identifier is NCT01238484, and it was last updated May 24, 2012. The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus. The estimated enrollment is 50 participants and the primary completion date was noted as January 2013, however, this is not completed at this time and it is now July 2013. The sponsor for this study is also Dynasplint Systems. Another Clinical Trial on ' Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial', is currently recruiting participants. The ClinicalTrial.gov. Identifier IS NCT01589679, and it was last updated on July 19, 2012. The purpose was to determine the efficacy of the 'Metatarsal Dynasplint Sytem' (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial. The estimated enrollment is 110, with the primary completion date noted as May 2013, however, this is not completed at this time and it is now July 2013. The sponsor for this study is also Dynasplint Systems. An interventional, randomized Clinical Trial on 'Dynamic Splinting After Total Knee Arthroplasty', is currently recruiting participants. The ClinicalTrial.gov. Identifier is NCT00857701. This was last updated on May 24, 2012. The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty. The estimated enrollment is 50 participants and the estimated primary completion date is May 2013. However, this study has not been completed at this time and it is now July 2013. The sponsor for this study is also Dynasplint Systems. Another interventional, randomized Clinical Trial on ' Toe Walker Gait Trial (TW)', is recruiting participants. The ClinicalTrial.gov. Identifier is NCT01208142, and it was last updated on May 24, 2012. The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers. For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynasplint was worn at night. The estimated enrollment is 50 participants and the estimated primary completion date is September 2016. The sponsor for this study is also Dynasplint Systems. In summary, the majority of the clinical trials noted above are ongoing, and at this time there are no completed study results to review on the dynasplint device. Although there are a number of small randomized controlled trials, many of the studies noted on dynasplint in thee peer reviewed literature were retrospective, case studies or case series.

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Scientific Rationale – Update November 2012 Dynasplint Systems, Incorporated (DSI) is a company that designs, manufactures and sells dynamic splints that are used for range of motion rehabilitation. Per the manufacturer, “The Jaw Dynasplint System is proposed in restoring physical function for patients suffering from joint or muscle stiffness and limited range of motion (ROM) in the posterior mandibular or temporomandibular (TMJ) region. Patients who have range of motion challenges in the facial muscles or jaw area may be very appropriate for this clinical solution. Oral challenges including: limited vertical ROM, lateral deviation, strengthening, and pain-free movement/mobility are commonly treated with the Jaw Dynasplint System. Functional limitations can be caused by: head and neck cancer, TMJ dysfunction, congenital/developmental conditions, osteoarthritis, fractures, trauma, infection, head and neck surgery, radiation therapy, burns, and scleroderma.” The temporomandibular joint (TMJ) is the articulation of the temporal and mandibular bones. TMJ dislocation occurs when the condyle travels anteriorly along the articular eminence and becomes locked in the anterior superior aspect of the eminence, preventing closure of the mouth. This results in stretching of the ligaments, and is associated with severe spasm of the muscles that open and close the mouth (i.e., the masseter, medial pterygoid, and temporalis). The resultant trismus prevents the condyle from returning to the mandibular fossa. TMJ dislocation is painful and frightening for the patient. On examination, the patient is unable to close the mouth and there is excessive salivation. A depression may be noted in the preauricular area. Palpation of the TMJ reveals one or both of the condyles trapped in front of the articular eminence and spasm of the muscles of mastication. Patients prone to mandibular dislocation include those with an anatomic mismatch between the fossa and articular eminence, weakness of the capsule and the temporomandibular ligaments (eg, patients with Ehlers-Danlos or Marfan syndrome), and torn ligaments. Patients who have had one episode of dislocation are predisposed to recurrence. Temporomandibular joint disorder (TMJ disorder) or trismus, which is an involuntary contraction of the jaw muscle causing a restriction of the mouth opening, is often seen in individuals with head and neck cancers. In patients with traumatic injuries, a panoramic radiograph of the jaw (or Panorex), if available, should be obtained to exclude a mandible fracture. If a panoramic radiograph is not available, computed tomography of the jaw should be obtained if fracture is strongly suspected because mandibular fractures may be missed on plain radiographs. Although radiographs are advised in most instances, patients with no trauma mechanism, typical clinical findings of TMJ dislocation, and no other clinical findings suggestive of fracture may undergo reduction without radiographs. The following patients should undergo prompt referral to an oral and maxillofacial surgeon:   

Patients with TMJ dislocation in association with a fracture Patients who have had more than two prior TMJ dislocations Patients who fail reduction attempts

There is no reference to using the Dynasplint for TMJ in the article, “Reduction of temporomandibular joint (TMJ) dislocation” noted in UpToDate (2012).

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Stubblefield et al. (2010) completed a retrospective cohort study on 20 patients with head and neck cancer and trismus. All patients underwent assessment by a boardcertified physiatrist and were referred to physical therapy for delivery of the dynasplint trismus system (DTS) and instructed to progress use of the DTS to 30 minutes 3 times a day. Additional modalities for the treatment of trismus including pain medications and botulinum toxin injections were prescribed as clinically indicated. Change in maximal interincisal distance (MID) as documented in the medical record. The use of the DTS as part of multimodal therapy including physical therapy, pain medications, and botulinum toxin injections as deemed clinically appropriate resulted in an overall improvement of the MID from 16.5mm to 23.5mm (P