| CTRI Number |
CTRI/2025/07/089979 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing how well two treatments — Myofascial Release and Tool-Assisted Soft Tissue Massage — work along with regular therapy to improve knee function in people with IT Band Friction Syndrome |
|
Scientific Title of Study
|
TO compare the effectiveness of myofascial release versus instrumental assisted soft tissue mobilisation with conventional therapy for iliotibialband friction syndrome to improve knee function |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farheen Qureshi |
| Designation |
Student |
| Affiliation |
Shri Guru Ram Rai Institute of Medical Health and Sciences |
| Address |
Physiotherapy Department ,North block, Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7900676095 |
| Fax |
|
| Email |
farheenf304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tabassum PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai Institute of Medical Health and Sciences |
| Address |
Physiotherapy Department ,North block, Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
tabassum@sgrrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai Institute of Medical Health and Sciences |
| Address |
Physiotherapy Department ,North block, Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
tabassum@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Farheen Qureshi |
| Address |
Physiotherapy Department ,North block, Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK,248001 |
| 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 |
| Farheen Qureshi |
Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK |
Physiotherapy Department ,North block, Shri Mahant Indiresh Hospital, Patel Nagar,Dehradun UK
Dehradun
UTTARANCHAL |
7900676095
farheenf304@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrumental assisted soft tissue mobilisation and myofascial release along with conventional therapy for illiotibial band friction syndrome to improve knee function |
8 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-60 years
pain over knee joint.
Post TKA Knee stiffness (above 3 months)
Normal alignment and implant
patient general health.
|
|
| ExclusionCriteria |
| Details |
Osteoporosis
Inadequate healing from TKA
Metal implant fixation in knee
Neurological or musculoskeletal conditions
Recent fracture in knee
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS SCALE ( visual analogue scale for pain)
ROM via goniometer
Special test –Ober’s test
Noble’s compression test
Renne’s test
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/07/2025 |
| 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="6"
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
|
Group A: IASTM with conventional therapy. 3 Alternative days for 8 weeks •Strokes: apply warm up strokes proximal to distal (long strokes 10 rep) •Focus on trigger points or tight fascial band (30-90 sec for each trigger point) •IASTM treatment will be given 2-5 min per session Group B: MFR with conventional therapy •Skin rolling: gently lift and roll the skin to detect and release fascial restrictions. •Sustained pressure: hold on a specific point for 90-120 seconds. Conventional therapy •Ultrasound-Ultrasonic therapy will be given. The frequency will be 100 Hz, pulse = 2:8 and the intensity will be 3 W/cm2. •The treatment time will be 3 min. •The radiation area will be 0.8 cm2 •Stretching exercise (twisted forward bend, side lying leg lift, bridging with theraband, side lying abduction with theraband),half spinal twist,revolved low lunge, eagle ,reclining eagle twist. |