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CTRI Number  CTRI/2024/07/070347 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To note the effect of Yoga against Regular physical exercises in shoulder stiffness in the Indian Population 
Scientific Title of Study   Yoga therapy versus Physical therapy as a supplement to treatment of frozen shoulder: A randomized controlled study in the Indian Populace 
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 Christina Boda 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Room No. 32 OPD, Department of Orthopaedics, AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Room No. 32 OPD, Department of Orthopaedics, AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Hyderabad
TELANGANA
508126
India 
Phone  9985326777  
Fax    
Email  dr.christinaboda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Christina Boda 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Room No. 32, Department of Orthopaedics, OPD,AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Room No. 32, Department of Orthopaedics, OPD,AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Hyderabad
TELANGANA
508126
India 
Phone  9985326777  
Fax    
Email  dr.christinaboda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Christina Boda 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Room No. 32, Department of Orthopaedics, OPD,AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Room No. 32, Department of Orthopaedics, OPD,AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Hyderabad
TELANGANA
500083
India 
Phone  9985326777  
Fax    
Email  dr.christinaboda@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bibinagar,Rangapur Village, Bibinagar Mandal, Yadadri Bhuvanagiri District, Telanagana 508126 
 
Primary Sponsor  
Name  Dr. Christina Boda 
Address  AIIMS Bibinagar,Rangapur Village, Bibinagar Mandal, Yadadri Bhuvanagiri District, Telanagana 508126 
Type of Sponsor  Other [SELF] 
 
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 Christina Boda  AIIMS Hospital, Bibinagar  Room No. 32, Department of Orthopaedics, OPD,AIIMS Bibinagar, Rangapur Village, Bibinagar, Yadadri Bhuvanagiri District
Hyderabad
TELANGANA 
9985326777

dr.christinaboda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physical Therapy 1. Wand exercises – Flexion, extension and external rotation 2. Finger ladder exercises 3. Wall Stretches pectoral stretches and biceps stretches 4. Active range of motion exercises (flexion and abduction) 5. Outward and Inward rotation exercises with resisted band 6. Isometric shoulder exercises   1. Wand exercises: Hold for 10 seconds x 15 reps – 2 sets 2. Finger ladder exercises: Hold for 10 seconds x 15 reps – 2 sets 3. Wall Stretches pectoral stretches and biceps stretches: Hold for 10 seconds x 15 reps – 2 sets 4. Active range of motion exercises: Hold for 10 seconds x 15 reps – 2 sets 5. Outward and Inward rotation exercises with resisted band: Hold for 10 seconds x 15 reps – 2 sets 6. Isometric shoulder exercises: Hold for 10 seconds x 15 reps – 2 sets  
Intervention  Yoga therapy 1. Sukshma vyayama 2. Gomukhasana stretch 3. Shashankasana Stretch 4. Makarasana relaxation technique 5. Shavasana Relaxation technique   1. Sukshma vyayama: 5-10 rounds for 10 secs 2. Gomukhasana stretch: 7 rounds with 15 secs 3. Shashankasana Stretch: 6 rounds with 10 secs 4. Makarasana relaxation technique: 10 rounds with 10 secs 5. Shavasana Relaxation technique: 30 secs – 2 sets  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult denovo detected periarthritic shoulder
Normal Xray of shoulder joint in AP view
 
 
ExclusionCriteria 
Details  Patients with history of trauma
Patients with osteoarthritic changes as seen in Xray
Any other pathological conditions of shoulder
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of the intervention of Yoga and physical therapy for frozen shoulder  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the outcome of shoulder active range of movements followed by yoga and physical therapy  3 months 
To observe effects in relation to age, sex, associated co morbidities with the intervention of yoga therapy and physical therapy in frozen shoulder.
 
3 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   26/07/2024 
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 Applicable 
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  

Adhesive Capsulitis/Frozen shoulder is often a self–limiting disease that globally restricts the shoulder movements. There would be active and passive limitation of movements mainly affecting forward flexion and external rotation with no abnormal joint involvement. This study focuses on patients with frozen shoulder who will receive conservative treatment along with either yoga therapy or physical therapy for a period of 3 months with regular interval follow- up and assess the pain and stiffness symptoms improvement. It will also compare the outcomes between the two groups.  The treatment modalities of Frozen shoulder include medication, local steroid injection, physiotherapy, hydrodistension, manipulation under anesthesia, arthroscopic capsular release and open capsular release(1). There is no consensus on the most efficacious treatment for this condition.

Physiotherapy is an initial therapy for idiopathic frozen shoulder, which encourages active assisted ROM exercise along with gentle passive stretching exercises including forward elevation, internal and external rotation and cross body adduction. These exercises are to be performed five to six times per day with each movement. Yogasana, which is a psychosomatic posture also impacts on the musculoskeletal system that helps in providing toned muscular strength, flexibility and coordination. Yoga postures also activate scapular stabilizing muscles along with shoulder mobility and flexibility.

Physical therapy will be localised to only individual muscle movement in the shoulder, whereas yoga therapy will focus on a group of muscles associated with adjacent structures (shoulder with chest and upper back).  Standard therapy for Frozen shoulder in the initial stages is mobilization of the joint, which is accomplished in both groups and hence does not compromise the patient care in both groups. However, the question remains: Is there any difference between physiotherapy and yoga therapy in improving the stiffness in patients with frozen shoulders? Hence, this study investigates their effectiveness.

 
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