A single center randomized parallel group clinical trial to compare the efficacy of Siddha Varmam Therapy and Thailam Application (SVT) versus Thailam Application (TA) in terms of pain and disability in the treatment of Kumbavatham (Adhesive capsulitis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- •Reduction in shoulder pain and improvement in range of movements of shoulder joint. It is assessed by Shoulder Pain and Disability Index – SPADI.
研究概览
简要总结
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 ≥ 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
•Reduction in shoulder pain and improvement in range of movements of shoulder joint. It is assessed by Shoulder Pain and Disability Index – SPADI.
时间窗: Screening, At the time of recruitment, End of the trial period. Time point: 6 weeks
次要结局
- •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.)