Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 8, 2024
Date Accepted: Feb 25, 2025
Evaluation of the Comparative Efficacy of Honey Thermal Microcautery, Standard Physiotherapy, and Sida cordifolia Oil via Nasal Administration in the Management of Frozen Shoulder: Protocol for a Randomized Controlled Trial
Background:
Frozen shoulder is a shoulder ailment that denotes dysfunction in the arm characterised by limited range of motion accompanied by pain. The prevalence of adhesive capsulitis is 3-5% in the general population and up to 20% in those with diabetes. Physiotherapy, analgesics, corticosteroids, and surgical capsulotomy are common forms of treatment. Administering oil through the nasal route (or Nasya karma) is mentioned in Ayurvedic Scriptures for managing the above neck and clavicle disorders. Thermal microcautery (or Agnikarma) is a parasurgical procedure for treating related pathologies of bodily humor (Vata and Kapha). This study will aim to compare the efficacy of Honey Thermal micro cautery versus Standard Physiotherapy versus cordifolia oil via nasal administration in the treatment of frozen shoulder to determine which provided the most relief.
Objective:
The primary aim is to evaluate the efficacy of Honey Thermal Micro Cautery, Standard Physiotherapy, and Sida Cordifolia Oil via Nasal Administration on VAS, R.O.M., and S.P.A.D.I., Mc Gill Pain Questionnaire and to compare these interventions. The secondary objective is to assess sustained relief in all three groups.
Methods:
We will enrol 60 patients, 20 in each group, for this single-blind accessor control study. Group A will receive Ayurvedic treatment, that is, Thermal micro cautery using honey for two days (1st and 7th ) and placebo capsules (twice per day) for seven days, and Group B will receive Standard Physiotherapy and placebo capsules (twice per day) for seven days; Group C will be given Sida cordifolia oil via nasal administration with eight drops in each nostril and placebo capsules (twice per day) for seven days. Evaluation Parameters: Pain (Visual Analog Scale - VAS), Range of Motion (R.O.M.) measured with a goniometer, Shoulder Pain and Disability Index (S.P.A.D.I.), Mc Gill Pain Questionnaire. On 18/09/2023, approval was received from the Institutional Ethics Committee Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), with Ref. No. MGACHRC/IEC/Sep-2023/740 C.T.R.I. registration No, C.T.R.I./2023/11/059594
Results:
The results will be subjected to statistical analysis using appropriate methods like ANOVA test. If ANOVA shows significance, post hoc tests (e.g. Tukey’s HSD) will identify group differences, with p<0.05 considered significance. As of January 2025, 16 patients have been recruited in all three groups, and the final results are expected to be published in November 2025
Conclusions:
This comparative study seeks to establish the most effective treatment among Honey Thermal Micro Cautery, Standard Physiotherapy, and Sida Cordifolia Oil Nasya for managing frozen shoulder, potentially offering new integrative approaches to treating this condition.
Clinicaltrial:
International Registered Report:
PRR1-10.2196/64066
Citation
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