| 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
|
|
|
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
|
|
|
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. |