跳至主要内容
临床试验/CTRI/2025/04/085690
CTRI/2025/04/085690尚未招募不适用

Long term effect of yoga asana- an adjunct therapy to conventional treatment in frozen shoulder.

No funding is required for my research1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年5月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
Shoulder pain and disability index(SPADI)

研究概览

简要总结

INTRODUCTION: Frozen shoulder, also known as adhesive capsulitis or periarthritis of the shoulder. It occurs due to an abnormal process happening in the glenohumeral joint, that is, synovial inflammation and capsular fibrosis, which leads to difficulty in activity of daily living due to pain and stiffness in the shoulder joint. Along with joint capsule tightness in surrounding structures like muscles, ligaments and tendon also gets affected. A frozen shoulder patient typically has insidious shoulder stiffness with severe pain that gets worsens at night, and they usually have near complete loss of active or passive external rotation of the shoulder joint. The prevalence of frozen shoulder ranging from 2 to 5% in the general population. Women are more prone than men. Diabetic patients are 2 to 4 times more likely to get frozen shoulder. Even diabetic patients are at higher risk for opposite shoulder joint involvement to an extent of 1 in 5. People of the age group between 35 to 65 are mainly affected. Frozen shoulder is of 2 types : primary or idiopathic and secondary. Primary or idiopathic frozen shoulder occurs without any specific trauma or history of injury and is often associated with other diseases and conditions, such as diabetes mellitus, and may be the first presentation of a diabetic patient. Secondary adhesive capsulitis has an underlying cause or associated pathological condition that may lead to reduced shoulder movement and hence develop frozen shoulder. Frozen shoulder, or ACS is divided into 4 stages based on duration and symptoms: Prefreezing, freezing (painful), frozen (adhesive) and thawing. Yoga asana is a very ancient science and has been practiced since ancient times. And it is being accepted by the western world. Yoga asana has showen beneficial effects in many chronic musculoskeletal diseases. . The word “yoga” means yuj, and it means to join or to unite; basically, it is derived from sanskrit roots. It also includes different techniques. According to medical scientists, “Yoga therapy is successful because of the balance it creates in the nervous and endocrine systems, which directly influences all the other systems and organs of the body.” Yoga is a type of practice that connects the breath, the body, and the mind, and it balances the whole person. 

NEED OF THE STUDY: To study the effect of long-term Yogasana with conventional physiotherapy for management of patient with frozen shoulder .As there are studies done on short term effect of yogasana an adjunct therapy to conventional treatment in frozen shoulder but not for long term effect. Even there is paucity of research done between such two management approach for long term effect.

METHODOLOGY: This will be a randomized controlled study. The patients will be selected as per the inclusion and exclusion criteria. Once patients agree to participate in the study patient information sheet will be given and written informed consent will be taken from all the selected subjects. Then patients will be allocated randomly into two groups through computer-generated random numbers. Patients will be divided into 2 groups : (A) control group (conventional Physiotherapy) and (B) experimental group (yoga asana and conventional physiotherapy). Before starting the intervention, all patient’s baseline data will be collected as per case report sheet. The experimental group will receive yogasana with conventional physiotherapy for 30 mins 5 days/week for 4 weeks and home exercise programme will be given to them for another 4 weeks using diaghramatic sheet with home diary for daily record. Adherence of home exercise program will be maintained via home diary. Patient will informed to maintain home diary on daily basis and verified by investigator. Tailor made protocol will be given to experimental group. In other hand, the control group will receive conventional physiotherapy for 30 mins 5 days/week for 4 weeks and home exercise programme will be given for another 4 week in form of diaghramatic sheet of conventional therapy with home diary for daily record. The patient will be advised to keep a daily diary at home, which the investigator will confirm. All the outcome measures will be observed at baseline, on 4th week and at the end of 8th week.

OUTCOME MEASURE: Shoulder pain and disability index (SPADI) for functional disability, Numerical pain rating scale(NPRS) for pain assessment. and goniometer for ROM or mobility assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Diagnosis of frozen shoulder made by orthopedic surgeon.
  • Moderate to severe pain and stiffness for 6 months prior to presentation.

排除标准

  • Patients who are not willing to participate.
  • History of trauma or recent injury.
  • Patients who had neurological condition disorders.
  • Patients who had undergone any surgery in shoulder.

结局指标

主要结局

Shoulder pain and disability index(SPADI)

时间窗: At Baseline, 4th week and at the end of 8th week.

次要结局

  • 1. Numerical pain rating scale(NPRS)(2. Goniometer)

研究者

发起方
No funding is required for my research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nirav Vaghela

K M Patel Institute of Physiotherapy

研究点 (1)

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