| CTRI Number |
CTRI/2025/06/089785 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| 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
|
Effects of thigh muscles release on pain , knee alignment in patients with knee osteoarthritis. |
|
Scientific Title of Study
|
Effects of Iliotibial Band Release with and without conventional exercises on pain, function, and tibiofemoral alignment in patients with knee osteoarthritis: An experimental 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 Neha Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| Address |
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| Address |
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Avantika Madgulkar |
| Designation |
Post Graduate |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| Address |
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Pune
MAHARASHTRA
411018
India |
| Phone |
9146693466 |
| Fax |
|
| Email |
madgulkaravantika5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
|
|
Primary Sponsor
|
| Name |
Dr Neha Kulkarni |
| Address |
Department of Musculoskeletal Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| 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 |
| Avantika Ganesh Madgulkar |
Dr D Y Patil College of Physiotherapy OPD |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18.
Pune
MAHARASHTRA |
9146693466
madgulkaravantika5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing the effects of release of IT band with conventional exercises in patients with knee OA |
Comparing the effects of release of IT band with conventional exercises in patients with knee OA for 4 weeks |
| Intervention |
Effects of IT band release with IASTM in patients with knee OA |
Release of IT band with IASTM in patients with knee OA and conventional exercise protocol for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
According to ACR criteria.
1) Age 50-65 years
2) Morning stiffness
3) Crepitus on active motions
4) Bony tenderness
5) Bony enlargement
6) No palpable warmth
7) Normal BMI
8) Tibiofemoral primary OA
9) Grade I and II (acc to kellegren-Lawrence)
10) Tightness of Iliotibial band : 24.59° ±
7.27°
|
|
| ExclusionCriteria |
| Details |
1) Recent fracture of upper limb and lower limb
2) Circulatory pathologies- such as DVT, Varicose veins
3) Any skin sensitivity issue
4) Past history of lower limb surgery.
5) Participants without tightness of IT band
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Ober’s test.
2)Visual Analogue Scale
3)Knee Osteoarthritis Outcome Score.
4)APECS AI Posture Evaluation and Correction System .
|
At base line and after 4 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
At base line and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/07/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
08/07/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 investigates how iliotibial (IT) band tightness is affected by Instrument Assisted Soft Tissue Mobilization (IASTM) in patients with Grade I and II knee osteoarthritis (OA). Pain, mobility, and quality of life are frequently impacted by knee OA, and tight IT bands exacerbate joint stress and inflammation. IASTM may provide longer-lasting advantages by reducing trigger points and enhancing load distribution, even while stretching has demonstrated temporary alleviation. Participants in this study range in age from 50 to 65 and meet ACR criteria with verified IT band tightness. Evaluating how well IASTM reduces pain, enhances knee function, and improves tibiofemoral alignment is the aim. |