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 an ailment that denotes dysfunction in the arm characterized by limited range of motion accompanied by pain. The prevalence of adhesive capsulitis is 3% to 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 the Ayurvedic scriptures for managing neck and clavicle disorders. Thermal microcautery (or agni karma) is a parasurgical procedure for treating related pathologies of bodily humors (vata and kapha). This study will aim to compare the efficacy of honey thermal microcautery, standard physiotherapy, and Sida 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 microcautery, standard physiotherapy, and S cordifolia oil via nasal administration using the visual analogue scale, range of motion, the Shoulder Pain and Disability Index, and the McGill Pain Questionnaire and compare these interventions. The secondary objective is to assess sustained relief in all 3 groups. Methods: We will enroll 60 patients, 20 in each group, for this single-blind assessor-controlled study. Group A will receive Ayurvedic treatment, that is, thermal microcautery using honey for 2 days (the first and seventh) and placebo capsules (twice per day) for 7 days, group B will receive standard physiotherapy and placebo capsules (twice per day) for 7 days, and group C will be given S cordifolia oil via nasal administration with 8 drops in each nostril and placebo capsules (twice per day) for 7 days. The evaluation parameters are pain (visual analogue scale), range of motion measured using a goniometer, the Shoulder Pain and Disability Index, and the McGill Pain Questionnaire. On September 18, 2023, approval was received from the Institutional Ethics Committee of Mahatma Gandhi Ayurved College Hospital and Research Centre (MGACHRC/IEC/Sep-2023/740). Results: The results will be subjected to statistical analysis using appropriate methods such as ANOVA. If the ANOVA shows significance, post hoc tests (eg, the Tukey honestly significant difference test) will identify group differences, with P<.05 considered significant. As of January 2025, a total of 16 patients have been recruited, divided into 3 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 microcautery, standard physiotherapy, and S cordifolia oil nasya for managing frozen shoulder, potentially offering new integrative approaches to treating this condition.