[Current Medical Practice (1981): 7, 285]

Role of Rumalaya in Cervical Spondylosis (A Clinical Trial) Singh, O.P., M.S. (Orth.), Lecturer, Jain, P., M.B.,B.S., Post-graduate Research Assistant And Singh, G.K., M.S. (Orth.), Chief Resident, Department of Orthopaedic Surgery, K.G.'s Medical College, Lucknow (U.P.), India.

INTRODUCTION Cervical spondylosis is a disease afflicting the inter-vertebral disc in the regions of cervical spine. It is characterised by the degeneration, protrusion, calcification and consequent pressure on the nerve roots of the cervical and brachial plexus. This results in severe debilitating syndrome of root irritation, root pains and muscle spasm. The aetiology of the condition is still unknown but shearing stress on the inter-vertebral disc on an accelerating or a braking scooter are said to be one of the precipitating factors acting on a degenerated and prematurely senile disc. The treatment of cervical spondylosis has mainly been diathermy, exercises, manipulations, tractions, immobilisation and drug therapy. The various modalities described above can be conveniently grouped into those required during acute phase of the disease and those needed to prevent acute exacerbations and for subsidence of chronic brachialgia. Present-day treatment has its own limitations and continuous research on new modes of therapy to afford faster relief of pain and prevention of its recurrence is still under way. This clinical trial was conducted to determine the efficacy and toxicity of Rumalaya in management of cases of cervical spondylosis.

MATERIAL AND METHODS One hundred and eleven cases of cervical spondylosis attending the Orthopaedic Wing of outpatients department of G.M. and Associated Hospitals, Lucknow, were subjected to this study. After thorough clinical evaluation, they were subjected to radiological and pathological investigations with a view to determine the severity of the conditions. The cases were managed by conservative treatment, which included diathermy, isometric exercises, traction, collar and Rumalaya therapy. The cases were regularly followed up to determine the efficacy of the treatment symptomatically, the duration of treatment required to achieve this relief and toxic effect of the drug, if any.

Table 1: Showing composition of Rumalaya tablets Each tablet of Rumalaya contains Mahayograj guggul 0.162 g Exts. Maharasnadi quath 65 mg Moringa pterygosperma 16 mg Pristimera indica 6 mg Rubia cordifolia 13 mg Tinospora cordifolia 10 mg Tribulus terrestris 16 mg Shilajeet (Purified) 16 mg Swarnamakshik bhasma 5 mg Shankh bhasma 65 mg Muskdana 10 mg Swarna (Gold) catalyst

Processed in Vitex negundo, Tinospora cordifolia, Ocimum sanctum, Eclipta alba, Withania somnifera, Zingiber officinale, Dashamoola. OBSERVATIONS One hundred and eleven cases (41 males, 70 females) attending the Outpatient Department of Orthopaedic Surgery were subjected to this study. The age range was from 17 to 81 years; the maximum number of cases being from ages 21 to 60 years. Female cases were more in all the age groups. Age group / years 10 - 20 21 - 30 31 - 40 41 - 50 51 - 60 61 - 70 71 - 81 Total

Table 2: Showing age incidence Male patients Female patients 1 6 11 13 10 17 11 20 7 13 0 1 1 0 41 70

Total 7 24 27 31 20 1 1 111

The duration of illness varied from 10 days to 10 years. 80.17% of cases reported within one year of illness as shown in Table 3 and the average duration of illness was 1 year and 5 months.

0-1 year

2-4 years 5-7 years 8-10 years

Table 3: Showing duration of illness Duration No. of patients 0-1 month 27 2-4 months 28 5-7 months 17 8-10 months 4 11-12 months 13 89 89 16 2 4 Total 111

Table 4 shows the incidence of various signs and symptoms observed in this series. From the analysis it can be inferred that incidence of trapezius tenderness was present in all but 4 cases. Vertebral tenderness was also high (present in 85 out of 111 patients). Most common movement to be limited was rotation (89 cases) and side-bending (86 cases).

Table 4: Showing symptoms and signs Symptoms and signs No. of patients Vertebral tenderness 85 Trapezius tenderness 107 Wasting 9 Referred pain to shoulder 24 Referred pain to arm and forearm 4 Movements limited Flexion 54 Extension 67 Side-bending 86 Rotation 89 Neurological signs and symptoms 13

In 24 cases, vague 'referred pain' spreading over the shoulder was noted and 4 cases out of them also had pain radiating along the arm and forearm, showing irritation of nerve roots. There was paraesthesia in the form of tingling of hands in 13 cases. Out of 111 patients, 59 cases were X-rayed. Table 5 summarises the radiological features. No. of patients X-rayed 2 ( 3.3%) 57 (96.6%) 3 ( 5.08%)

Table 5: Showing radiological changes Radiological signs observed No sign Degeneration and narrowing of I.V. disc with formation of osteophytes Facet joint affected

In most, the other investigations were found to be within normal limits of the patients. Even if they were abnormal, the cause of abnormality was found to be other than cervical spondylosis. In 24 cases subjected to Rose Waller Test only one was doubtfully positive (1:16) suggesting that there was rheumatological overlay. The treatment received by the patients is summarised in Table 6.

Heat

Exercises Drugs

Treatment S.W.D. I.R. exposure P/W bath shoulder Cervical ext. exercises Shoulder mobilising exercises Rumalaya tablets Rumalaya cream Surgery

Table 6 No. of patients 31 80 4 111 4 111 111 Nil

Dose On alternate days once

3 times daily 2 t.i.d., for 3 days, 1 q.i.d. for 3 days followed by 1 t.i.d. till pain is relieved

RESULTS The overall results of the study in terms of relief, various signs and symptoms in response to Rumalaya therapy are summarised in Table 7. The response to Rumalaya tablets and cream can be determined by analysis of the symptoms relieved. Out of a total of 85 patients having vertebral tenderness. 40 patients (47.1%) got partial relief whereas 28 patients (32.9%) had complete relief. Thus 68 out of 85 patients (80%) were relieved of vertebral tenderness, partially or wholly. In cases of trapezius tenderness, out of 107 cases, 28 patients got complete relief while 52 obtained partial relief. Thus a total of 80 out of 107 cases complaining of trapezius tenderness were relieved wholly or partially of the symptoms, giving an overall response of 74.8%.

Symptoms and signs Vertebral tenderness Trapezius tenderness Wasting Referred pain to shoulders Refereed pain to arm and forearm Movement Limited: Flexion Extension Side-bending Rotation Neurological signs and symptoms

Table 7: Showing symptoms and signs relieved by Rumalaya Complete Partial relief Total relief relieved Temp. Perm. Total Total 22 (25.9%) 18 (21.2%) 40 (47.1%) 28 (32.9%) 68 (80.0%) 34 (31.8%) 18 (16.8%) 52 (48.6%) 28 (26.2%) 80 (74.8%) 0 6 (66.6%) 6 (66.6%) 0 6 (66.6%) 0 18 (75%) 18 (75%) 6 (25%) 24 (100%)

Total patients complaints 85 107 9 24

0

4 (100%)

4 (100%)

0

4 (100%)

4

20 (37.0) 31 (46.3) 45 (52.3) 48 (53.9)

18 (33.3) 18 (26.8) 18 (20.9) 18 (20.2)

38 (70.3) 49 (73.1) 63 (73.2) 66 (74.1)

12 (22.2) 12 (17.9) 12 (14.0) 12 (13.5)

50 (92.5) 61 (91.0) 75 (87.2) 78 (87.6)

54 67 86 89

0

7 (53.8)

7 (53.8)

6 (46.2)

13 (100%)

13

Fig. 1: X-ray of cervical spine (P.A. view) shows osteophytes in C4, C5 and C6. The case was diagnosed as cervical spondylosis and treated with Rumalaya. After 21 days' treatment, patient obtained complete relief from pain and other symptoms.

Fig.2. Case No.24, female aged 45. X-rays of left knee (P.A. view and lateral view) show osteophytes. Diagnosis: Osteoarthritis left knee. After 27 days' treatment with Rumalaya, patient regained full movement of the knee and could squat without support.

Case No.71, female patient with history of osteoarthritis of both knees since 2 years. X-ray shows medical narrowing and spiking due to osteophytes at the margin. After Rumalaya for 27 days, pain was relieved, full movement of knees become possible and patients could squat with support.

Thus, out of 9 cases having muscle wasting 6 recovered fully. So also all cases of shoulder pain, radiating pain to the arm and forearm and other neurological symptoms recovered fully with Rumalaya therapy. Restricted movements of flexion and extension showed improvement with Rumalaya in 92.5% and 91% cases respectively. Movement of side bending and rotation, which were, limited more than other movements showed relief in 87% cases. The duration of Rumalaya therapy required to achieve these results varied from 10 days to 2 months. In the courses of treatment, no toxicity of any sort of undesirable side-effects were encountered with Rumalaya except for 5 cases of flatulence which might have had no relevance to the treatment. SUMMARY 1. A clinical trial was conducted in 111 cases of cervical spondylosis to assess the efficacy of Rumalaya cream and tablets. 2.

The patients were given conservative treatment like diathermy and exercise along with Rumalaya therapy.

3.

In 85 patients with vertebral tenderness, 28 patients had complete relief with Rumalaya.

4.

In 107 patients complaining of trapezius tenderness, 28 got complete relief whereas 52 got partial relief.

5.

Patients who had shoulder pain and pain radiating to the arm and forearm were fully relieved with Rumalaya.

6.

Restricted movements of flexion, extension, side bending and rotation were relieved in 92.5%, 91%, 87.2% and 87.6% of cases respectively. Neurological symptoms by way of paraesthesia were relieved in all the 13 cases.

7.

The duration of treatment varied from 10 days to 2 months, and no toxicity or adverse side effects was encountered.