| CTRI Number |
CTRI/2025/12/099883 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| 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
|
A Study of People with Front Knee Pain: Comparing Hands-On Muscle Release and Foam Rolling for Reducing Pain and Improving Knee Movement and Leg Flexibility |
|
Scientific Title of Study
|
Comparison between Effect of Myofascial Release and Foam Roller on Pain, Range of Motion of Knee Joint, Flexibility of Hamstring and Iliotibial Band in Patients with Patellofemoral Pain Syndrome: 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 Aditi Vijay Kadam |
| Designation |
PG student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Block J Raghunath Vihar Sector 14 Kharghar Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
7039760439 |
| Fax |
|
| Email |
aditikadam0926@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ruturaj Shete |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Block J Raghunath Vihar Sector 14 Kharghar Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9870881008 |
| Fax |
|
| Email |
ruturaj.53@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ruturaj Shete |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Block J Raghunath Vihar Sector 14 Kharghar Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9870881008 |
| Fax |
|
| Email |
ruturaj.53@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of Musculoskeletal Physiotherapy Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Plot No 3 Block J Raghunath Vihar Sector 14 Kharghar Navi Mumbai- 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
Plot No 3 Block J Raghunath Vihar Sector 14 Kharghar Navi Mumbai- 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditi Vijay Kadam |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of Musculoskeletal Physiotherapy Block J Raghunath Vihar Sector 14 Kharghar -410210 Navi Mumbai Raigarh MAHARASHTRA |
7039760439
aditikadam0926@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee (Academic) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foam Rolling |
Foam Rolling to Hamstring and Iliotibial Band.Conventional treatment includes stretching of the lower limb muscles and strengthening of hip and knee muscles.Above treatment is given for thrice a week for 4 week. Total duration: 30 minutes |
| Comparator Agent |
Myofascial Release |
Myofascial Release to Hamstring and Iliotibial Band.Conventional treatment includes stretching of the lower limb muscles and strengthening of hip and knee muscles.Above treatment is given for thrice a week for 4 week. Total duration: 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Reproduction of Retro patellar and Peripatellar pain while walking stairs squatting running cycling or sitting with flexed knee.
2) Positive patellar tilt test.
3) Moderate pain Intensity 3-7 on VAS Scale
4) Age group 18 to 45 years old
5) Both males and females
6) Hamstring and Iliotibial Band Tightness |
|
| ExclusionCriteria |
| Details |
1)Patients with history of History of knee surgery or fracture.
2)Presence of inflammatory or systemic conditions (eg: rheumatoid arthritis).
3) Any other Neurological disorders affecting the lower limb.
4) Pathological conditions of knee involving synovitis Osgood- Schlatter’s disease meniscal or intraarticular conditions.
T5)hose with referred pain from hip back and sacroiliac joint. |
|
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tightness of Hamstring and Iliotibial Band
Pain
Range of Motion of Knee Joint |
Baseline(Pre Intervention) on Day 1 then after 4 weeks of Intervention (Post Intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/01/2026 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 Myofascial Release and Foam Rolling techniques in patients with Patellofemoral Pain Syndrome. Participants will be randomly assigned to either the Myofascial Release group or the Foam rolling group. Both interventions target the soft tissues around the knee, hamstring, and iliotibial band to reduce pain and tightness.
Outcome Measures: 1) Visual Analogue Scale - It measures the amount of pain that patient feels. The ends are defined as the extreme limits of pain oriented from left (worst) to the right (best) 2) Range of Motion of Knee Joint- Goniometer will be used to measure the range of motion of Knee Joint. 3) 90-90 Straight Leg Raise Test - This test is used to assess the flexibility of Hamstring. 4) Modified Ober’s Test – This test is used to assess the flexibility of Ilio-Tibial Band.
Pre-intervention screening and assessment will be done.
GROUP A: Myofascial release and Conventional physiotherapy (MFR for hamstring) • Patient position: Prone lying • Hamstring area was exposed • Light stroking using hand over hamstring muscle from proximal to distal of the hamstring (2-3 minutes) • Compression of the posterior thigh (2-3 minutes) Cross hand release technique for hamstring 120seconds, 5 repetition/session. • Myofascial release is given with ulnar border from proximal to distal direction with light gentle pressure over the hamstring muscle until the slack in the skin is loosened.
(MFR for iliotibial band) • Patient position- side lying on unaffected side with hip and knee 30 degree flexed • Technique- soft fist or elbow used to engage the fasciae at the greater trochanter. • Then sustain gentle pressure in inferior direction at the line with the fibers of IT band from femur towards the knee. • This pressure then should be held for 90 seconds followed by 60 seconds of rest period and repeated for 5 minutes. • Neuromuscular technique (longitudinal stroke)- the thumb is placed over the taut band and longitudinal strokes are applied slowly with moderate pressure; this technique is applied for 3 minutes.
Group B: Foam Rolling and Conventional Physiotherapy (Foam Rolling for Ilio-Tibial Band) • With a roller you can be extremely targeted on the spots that are hot and work up and down its entire length. • Sit sideways on your roller, then rest your upper bodyweight on your hands. • Bend the non-rolling leg so the lower section is touching the floor, then slightly straighten it so that the roller moves down from your hip towards your knee. • This may be the most painful of all the moves you do, but try to keep the roller moving super slow so that you get a prolonged period of squeezing against the muscle. • When you get close to the bony section of the knee, change direction and repeat.
(Foam Rolling for Hamstring) • Sit on top of the roller, with pressure on one leg. • Your starting point is on the outside of the leg that you are rolling, just behind the knee. • Place your hands behind you for balance and, as you start the movement, push downwards with your arms. • Your aim is to let the roller move halfway up the back of your thigh, then as you roll back down towards the start position, make sure you have a subtle corkscrew action so you finish at the outside of your knee.
Conventional Physiotherapy • Stretching of hamstrings, plantar flexors, quadriceps, iliotibial band 3 reps with 30 second each. • Iliopsoas strengthening in non weight bearing 3 sets with 10 reps each. • Seated knee extension 90-45 degree 3 sets with 10 reps each. • Leg press and squatting 0-45 degree 3 sets with 10 reps each. • Hip abduction against elastic band(standing) & with weights (side-lying) 3 sets with 10 reps each. • Hip external rotation against elastic band(sitting) 3 sets with 10 reps each • Side-stepping against elastic band 3 sets with 10 reps each. • Maximum resistance will be given that enables 10 repetitions • Load was 70% of the 1-repetition maximum. Treatment will be given for 3 days in a week for a period of 4 weeks, total 12 sessions.
Post-Intervention assessment will be done. Data collected will be analysed and results will be drawn. Based on the results, a conclusion will be given. |