| CTRI Number |
CTRI/2021/09/036342 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study on the Effect of Release and Pressure with Movement release on Shoulder Muscle with Painful Points |
|
Scientific Title of Study
|
A Comparative study on the Effect of Myofascial Release (MFR) and Strain-Counterstain (SCS) on Upper Trapezius Myofascial Trigger Points |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasi Navale |
| Designation |
Mater of Physiotherapy Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy department, 12 Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9579117271 |
| Fax |
|
| Email |
manasinavale07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan D |
| Designation |
Associate Professor Musculoskeletal Department |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy department, 12 Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan D |
| Designation |
Associate Professor Musculoskeletal Department |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy department, 12 Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy Thube Park Shivaji Nagar Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Manasi Navale |
Sancheti Hospital Institute for Orthopedics and Rehabilitation |
16, floor-1, Department of musculoskeletal physiotherapy, Shivaji Nagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9579117271
manasinavale07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial Release |
3 days per week for 2 weeks |
| Comparator Agent |
Strain Counterstain |
3 days per week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pain on Visual Analogue Scale >4/10
Patient with trigger points in upper trapezius muscle
Reduced Cervical lateral flexion and rotation Range of mothion at least by 10 degree
|
|
| ExclusionCriteria |
| Details |
Patient with fibromyalgia syndrome
History of whiplash injury
History of cervical spine surgery
Patient with cervical radiculopathy or myelopathy determined by their primary health care physician
Having undergone myofascial pain therapy within the past month before the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Pain Pressure Threshold
Neck Disability Index |
At Baseline, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inclinometer |
At Baseline, 2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2021 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Randomized active control, parallel group that studies the effect of myofascial release and strain counterstain in upper trapezius myofascial trigger points. The one group will receive Myofascial Release and one group will receive strain counterstain technique and both group will receive conventional therapy. The duration of intervention for both the groups for 3 times per week for 2 weeks, total 6 sessions. The outcome measures for pain (Visual Analogue Scale), Range of Motion (Inclinometer), Pain Pressure Threshold (Algometer), Neck Disability Index would assessed before and after 2 weeks of Intervention |