| CTRI Number |
CTRI/2025/08/092178 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Shoulder Joint Mobilization and Trapezius Myofascial Release with Heat Therapy for Pain Relief and Mobility in Frozen Shoulder |
|
Scientific Title of Study
|
Effectiveness of Glenohumeral mobilization versus Myofascial release of Trapezius Muscle along with thermal Stimulation For pain and Rom in Subject 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 |
Vaishnavi Rathod |
| Designation |
Student |
| Affiliation |
Shri Guru Ram Rai University of medical And Health Science |
| Address |
Shri Mahant Indiresh Hospital North Block Physiotherapy Dept Room no - 2
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9860315482 |
| Fax |
|
| Email |
vaishnavi.rathod3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar |
| Designation |
Assistant professor |
| Affiliation |
Shri Guru Ram Rai University of medical And Health Science |
| Address |
Shri Mahant Indiresh Hospital North Block Physiotherapy Dept Room no - 2
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9412468744 |
| Fax |
|
| Email |
drskumarmalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Rathod |
| Designation |
Student |
| Affiliation |
Shri Guru Ram Rai University of medical And Health Science |
| Address |
Shri Mahant Indiresh Hospital North Block Physiotherapy Dept Room no - 2
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9860315482 |
| Fax |
|
| Email |
vaishnavi.rathod3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaishnavi Rathod |
| Address |
North block Physiotherapy Department room no 3 Shri Mahant Indiresh Hospital Patel Nagar Dehradun UK |
| 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 Sandeep Kumar PT |
Department of Physiotherapy, Shri Mahant Indiresh Hospital |
Patel Nagar, Dehradun – 248001, Uttarakhand, India
Dehradun
UTTARANCHAL |
9412468744
drskumarmalik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Guru Ram Rai Institute of Medical And Health Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frozen shoulder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - Glenohumoral joint Mobilization with thermal stimulation
|
Group 1 - Participants will receive glenohumeral mobilization techniques (anterior, posterior, and inferior glides) based on the direction of restriction. The intervention will be given 3–5 times per week for 3–4 weeks, along with standard warm-up exercises
|
| Intervention |
Group 2 - Myofascial release of Trapezius muscle with thermal Stimulation
|
group 2- Participants will receive myofascial release to the upper trapezius muscle along with pre-treatment thermal stimulation using a moist hot pack for 15–20 minutes. The intervention will be delivered 3–5 times per week for 3–4 weeks, along with standard shoulder mobility exercises |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of frozen shoulder (adhesive capsulitis)
2. Pain and restricted shoulder range of motion for at least 3 months
3. Age group between 30 to 60 years
4. Both male and female subjects
5. Willing to participate and provide informed consent
6. No history of trauma or fracture to the affected shoulder |
|
| ExclusionCriteria |
| Details |
Patients with rotator cuff tears or severe osteoarthritis of the shoulder
2. Neurological disorders affecting shoulder movement
3. Recent shoulder surgery (within the past 6 months)
4. Contraindications to heat therapy
5. Patients who received corticosteroid injections in the affected shoulder within the past 1 month
6. Uncontrolled systemic conditions (e.g., uncontrolled diabetes, thyroid dysfunction)
7. Any diagnosed malignancy or infection in the shoulder region |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS
SPADI(Shoulder pain and disability index) |
6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in functional ability using Shoulder Pain and Disability Index (SPADI)
Change in shoulder range of motion (flexion, abduction, external rotation) measured using goniometer
Participant satisfaction level based on verbal feedback or questionnaire |
Baseline (0 week), Midpoint (3rd week), Post-intervention (8th week) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/08/2025 |
| 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="0"
Months="3"
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
|
This study aims to compare the effectiveness of Glenohumeral Joint Mobilization versus Myofascial Release (MFR) of the trapezius muscle along with Thermal Stimulation in subjects diagnosed with frozen shoulder. A total of 30 participants will be randomly divided into two groups: Group A will receive Glenohumeral Mobilization and Thermal Stimulation, and Group B will receive MFR and Thermal Stimulation. The interventions will be administered three times per week for 8 weeks. The primary outcome measures include pain (VAS) and shoulder range of motion (ROM), while functional outcome will be assessed using the Shoulder Pain and Disability Index (SPADI). The study is designed to evaluate and compare the efficacy of these two commonly used physiotherapy approaches in reducing pain and improving ROM in patients with adhesive capsulitis. |