Effect of Siddha Varmam therapy for the treatment of shoulder pain and disability.

Phase 2

Completed

• Conditions: Adhesive capsulitis of shoulder,

• Registration Number: CTRI/2020/08/027350
• Lead Sponsor: Central Council for Research in Siddha

Brief Summary

This study is a randomized parallel group clinical trial which compares the efficacy of Siddha Varmam therapy and Thailam application with that of Thailam application in Kumbavatham patients. i.e, adhesive capsulitis. The thailam used is Vatha kesari thylam. Varmam points employed are those mentioned in the text ’Guidelines for practice of Siddha Varmam therapy, 1stEdition, 2017, Central Council for Research in Siddha, Ministry of AYUSH, Govt.of India’ . Patients aged between 35 years to 65 years with shoulder pain ( >=70% by SPADI) lasting for more than a month and range of motion limited by at least 25% in one or more directions measured using Goniometer. Male, female and transgender patients having complaints â‰¥ 3 months will be enrolled. Patients having history of Rotator tear, traumatic history, history of surgery in shoulder joint in the preceding 1 year, patients who underwent Varmam treatment/any other external treatment for kumbavatham within last three months prior to enrolment, history of fracture in clavicle, humerus, scapula and bones of upper limbs, osteoarthritis shoulder, Cervical neuropathy, paralysis, neurological disorder, shockwave or injection therapy in shoulder joint, Ischemic Heart Disease, rheumatoid arthritis, dislocation, osteoporosis, lifting heavy weight in routine life, pregnancy, lactation will be excluded. The pain and disability will be assessed by SPADI and the quality of life will be assessed using SF -36 questionnaire. The study centre is Siddha Central Research institute, Chennai. The adverse events if any will be informed to the pharmacovigilance cell of SCRI. The trial duration is 6 weeks and the patients will be instructed to come 3 days in a week  on alternate days. They will be followed up for 2 weeks. Seperatedata collection forms will be used for data collection. Appropriate statistical methods will be used for data analysis. The outcome of the study will be published in a peer reviewed journal.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-23
• Study Completion: 2023-04-30
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients with shoulder pain > 70% SPADI lasting for more than a month and range of motion limited at least 25% in one or more directions measured using Goniometer.
• 2.Duration of complaints > 3 months.

Exclusion Criteria

• 1.History of Rotator tear, traumatic history, history of surgery in shoulder joint in the preceding 1 year, patients who underwent Varmam treatment/any other external treatment for kumbavatham within last three months prior to enrolment, history of fracture in clavicle, humerus, scapula and bones of upper limbs, osteoarthritis shoulder, Cervical neuropathy, paralysis, neurological disorder, shockwave or injection therapy in shoulder joint, Ischemic Heart Disease, rheumatoid arthritis, dislocation, osteoporosis, lifting heavy weight in routine life, pregnancy, lactation.
• 2.Intervention model: parallel assignment.
• 3.Arms: 2 (Experimental arm-2) 4.Experimental arm 1: Thailam Application.
• 5.Experimental arm 2: Varmam + Thailam Application.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Reduction in shoulder pain and improvement in range of movements of shoulder joint. It is assessed by Shoulder Pain and Disability Index – SPADI.	Screening, At the time of recruitment, End of the trial period. Time point: 6 weeks

Secondary Outcome Measures

Name	Time	Method
•Quality of life of trial participants. It will be assessed by Quality of life questionnaire. (SF-36 questionnaire).	•End point classification: SPADI, SF-36, Safety Parameters.

Trial Locations

Locations (1)

Siddha Central Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Siddha Central Research Institute

🇮🇳Chennai, TAMIL NADU, India

Dr S Natarajan

Principal investigator

9843086050

dcr.scri@hotmail.com