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CTRI Number  CTRI/2025/04/085690 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 29/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Physiotherapy including YOGA]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Benefits of yoga and physiotherapy in patients with frozen shoulder. 
Scientific Title of Study   Long term effect of yoga asana- an adjunct therapy to conventional treatment in frozen shoulder. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirav Vaghela  
Designation  Professor 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9428647304  
Fax    
Email  niravpv@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Xama Patel 
Designation  MPT Student 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9427487360  
Fax    
Email  xamapatel050301@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Xama Patel 
Designation  MPT Student 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9427487360  
Fax    
Email  xamapatel050301@gmail.com  
 
Source of Monetary or Material Support  
K.M.Patel institute of physiotherapy, shree krishna hospital, karamsad 
 
Primary Sponsor  
Name  No funding is required for my research  
Address  NIL 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirav Vaghela  Shree Krishna Hospital  OPD no. 152, K M Patel Institute of Physiotherapy, Karamsad, Anand, Gujarat, India 388325
Anand
GUJARAT 		 9428647304

niravpv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional physiotherapy  The control group will undergo conventional physiotherapy, which consists of exercises like pendulums, finger ladders, back climbing, circumduction, and pulleys for 5 to 10 repetitions for 30 minutes, 5 days a week, for 4 weeks. For an additional 4 weeks, the group will receive a home exercise program in the form of a diagrammatic sheet of conventional therapy with a home diary for daily documentation. The investigator will verify the patients recommendation to maintain a daily journal at home. All the outcome measures will be observed at baseline, on the 4th week, and at the end of the 8th week. 
Intervention  Yoga and conventional physiotherapy  The experimental group will perform 5 to 10 repetitions of various yoga postures, such as Tadasana, Ardhkatichakrasana, Katichakrasana, Shashangasana, and Bhujanasana, with conventional physiotherapy for thirty minutes. For four weeks, they will work out five days a week, and for the remaining four weeks, they will use a diagrammatic sheet with a home diary to record their daily activities. A home journal will be used to ensure that the workout regimen is followed. The patient will be advised to keep a daily home journal, which the investigator will confirm. The experimental group will receive a tailor made protocol. All the outcome measures will be observed at baseline, on 4th week and at the end of 8th week. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Diagnosis of frozen shoulder made by orthopedic surgeon.
2. Moderate to severe pain and stiffness for 6 months prior to presentation. 
 
ExclusionCriteria 
Details  1. Patients who are not willing to participate.
2. History of trauma or recent injury.
3. Severe hearing, visual or sensory impairment.
4. Patients who had neurological condition disorders.
5. Patients who had undergone any surgery in shoulder.
6. Cervical pain radiating to the arm. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Shoulder pain and disability index(SPADI)
 		 At Baseline, 4th week and at the end of 8th week. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Numerical pain rating scale(NPRS)
2. Goniometer 		 At Baseline, 4th week and at the end of 8th week. 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.
 
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