| CTRI Number |
CTRI/2022/09/046090 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| 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
|
Effectiveness of Myofascial Release (MFR) versus Dry Needling in Subscapularis Trigger Points in Frozen Shoulder. |
|
Scientific Title of Study
|
Effect of Myofascial Release Versus Dry Needling in Subscapularis Trigger Points in Frozen Shoulder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiology, 1st cabin, 3rd floor, Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiology, 1st cabin, 3rd floor, Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupinder Kaur Bhatti |
| Designation |
PG Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
PG 1 Classroom, 3rd floor, Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7507612301 |
| Fax |
|
| Email |
mona_bhatti2301@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Physiotherapy, Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiology, 1st cabin, 3rd floor, Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune |
| 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 Amita Aggarwal |
Dr. D. Y. Patil College of Physiotherapy, Pune |
Physiotherapy OPD, basement, Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune.
Pune
MAHARASHTRA |
7986972513
amitapgi15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. D. Y. Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling |
Dry needling of subscapularis muscle trigger points using the piston and fishing method (10 minutes).
Conservative protocol - assisted shoulder flexion, assisted shoulder extension, codman exercises ( 10 repetition for 5 days, 3 times a day), anterior capsule stretch, posterior capsule strrtch, coraco-humeral ligament stretch (30 seconds hold, 3 repetitions), shoulder retraction, isometric shoulder external rotations (10 repetitions), hot pack (20 minutes)
|
| Intervention |
Myofascial Release |
Focused myofascial release with arm pull technique for subscapularis muscle trigger points (5 repetitions, each stretch position will be held for 90 seconds.
Total duration will be for 10 to 15 minutes. On day 1, 3, 5)
Conservative protocol - assisted shoulder flexion, assisted shoulder extension, codman exercises ( 10 repetition for 5 days, 3 times a day), anterior capsule stretch, posterior capsule strrtch, coraco-humeral ligament stretch (30 seconds hold, 3 repetitions), shoulder retraction, isometric shoulder external rotations (10 repetitions), hot pack (20 minutes)
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Medically diagnosed frozen shoulder patients, Aged between 40-65 years, Both male and female patients. Patients with complain of shoulder pain for last 3 months, Patients willing to give consent, Myofascial trigger points at subscapularis muscle, Stage 1 and stage 2 frozen shoulder patients. |
|
| ExclusionCriteria |
| Details |
Skin disorder over the neck and shoulder region
History of neck surgery, Taken antiplatelet therapy within the past three days of the study, Received steroid injections to shoulder joint within past three months of the study, Extreme fear of needles
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure Pain Threshold, Numerical Pain Rating Scale (NPRS),Shoulder Range of Motion, Shoulder Related Functions Test, Shoulder Pain And Disability Index (SPADI) |
Pre Intervention, Post Intervention - day 1, Day 5, Follow up - Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability of Arm, Shoulder and Hand Questionnaire (DASH), Shoulder Girdle Mobility |
Pre Intervention, Post Intervention - day 1, Day 5, Follow up - Day 10 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/10/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•NULL HYPOTHESIS: Both Myofascial Release and Dry needling have equal effects in Subscapularis trigger points on Pressure Pain Threshold, Range of Motion and Functional Outcome in Frozen Shoulder. •ALTERNATIVE HYPOTHESIS (H1): Myofascial Release has a greater effect than Dry Needling in Subscapularis trigger points on Pressure Pain Threshold, Range of Motion and Functional Outcome in Frozen Shoulder. •ALTERNATIVE HYPOTHESIS (H2): Dry Needling has greater effect than Myofascial Release in Subscapularis trigger points on Pressure Pain Threshold, Range of Motion and Functional Outcome in Frozen Shoulder.
AIM : To find the effects of myofascial release versus dry needling in subscapularis trigger points on pressure pain threshold, range of motion and functional outcome in frozen shoulder.
OBJECTIVES : 1.To find the effect of Myofascial Release versus Dry Needling in subscapularis trigger points on pressure pain threshold in frozen shoulder patients using Algometer and NPRS. 2.To find the effect of Myofascial Release versus Dry Needling in subscapularis trigger points on range of motion of shoulder in frozen shoulder patients using Universal Goniometer. 3.To find the effect of Myofascial Release versus Dry Needling in subscapularis trigger points on functional outcome in frozen shoulder patients using Function-Related Shoulder tests and SPADI. |