| CTRI Number |
CTRI/2025/03/083711 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Myofascial Release vs. Dynamic Cupping: Which is More Effective for Frozen Shoulder |
|
Scientific Title of Study
|
Effectiveness of Myofascial Release Versus Dynamic Cupping on Pain, Range of Motion and Functional Mobility in Patients with Frozen Shoulder: A Comparative Study |
| 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 Kiran Chandrakant Yadav |
| Designation |
Masters of Musculoskeletal Physiotherapy Student |
| Affiliation |
Maharashtra Institue of Physiotherapy Latur |
| Address |
Maharashtra Institute of Department of Musculoskeletal Physiotherapy ,OPD-15,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
MAHARASHTRA
413531
India
Latur
MAHARASHTRA
413531
India |
| Phone |
9145669008 |
| Fax |
|
| Email |
kiranyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Risha Kamble |
| Designation |
Associate Professor of Musculoskeletal Physiotherapy Department |
| Affiliation |
Maharashtra Institue of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Department of Musculoskeletal Physiotherapy ,OPD-15,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
MAHARASHTRA
413531
India
Latur
MAHARASHTRA
413531
India |
| Phone |
9730857306 |
| Fax |
|
| Email |
rishakamble9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Risha Kamble |
| Designation |
Associate Professor of Musculoskeletal Physiotherapy Department |
| Affiliation |
Maharashtra Institue of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Department of Musculoskeletal Physiotherapy ,OPD-15,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
MAHARASHTRA
413531
India
MAHARASHTRA
413531
India |
| Phone |
9730857306 |
| Fax |
|
| Email |
rishakamble9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy, Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR medical campus
Ambajogai Road Latur
Latur
MAHARASHTRA
513531
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kiran Chandrakant Yadav |
Maharashtra Institue of Physiotherapy Latur |
Maharashtra Institute of Physiotherapy MIMSR medical campus
Ambajogai Road Latur
Latur
MAHARASHTRA
513531
India
Latur
MAHARASHTRA |
9145669008
kiranyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic Cupping |
Dynamic cupping for will be used b sliding the cup with suction on body o shoulder muscle - pectoralis major minor and deltoid and subscapularis and trapizus. 3 times in a week for 2 weeks |
| Comparator Agent |
Gross and Focused Myofacial Release |
In Gross and focused MFR Given on pectoralis, deltoid, subscapularis and trapezius along with the conventional therapy 3 times in a week for 2 week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patient clinically diagnosed with unilateral frozen shoulder.
-Stage II frozen shoulder
-Age between 40 years to 65 years.
-Both genders male and female.
|
|
| ExclusionCriteria |
| Details |
-History with major shoulder injury or surgery.
- Patients with cervical radiculopathy, paresis or other
neurological changes in the upper limb on the involved side.
- Presence of underlying fracture associated inflammatory
arthritis.
- Any psychological disorder likely to interfere with the course
or assessment of the intervention process.
- Uncontrolled diagnosed neurological diseases,
immunodeficiency, bleeding disorders and allergies.
- Acute infections, using anticoagulants, severe cardiac issues,
under pacemaker and Hemophillia and similar conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Visual
analogue scale
(VAS)
2)Goniometer
3)Shoulder pain
and disability
index(SPADI) |
Pre and Post treatment effect will be assessed at 0 week and after 2 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
22/04/2025 |
| 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 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
|
Approval for the research work will be obtained from Institutional Ethical committee. The purpose of the study will be explained to each participant and a written informed consent will be taken in a language they understand. Participants will be screened and recruited for the study on the basis of inclusion and exclusion criteria. Participants will be indexed as per their visit in OPD. Participants will be added in group A and group B by simple random sampling. Subjects in Group A, myofascial release in which gross and focused myofascial release technique along with conventional physiotherapy will be given. Subjects in Group B will receive dynamic cupping technique along with conventional physiotherapy. |