| CTRI Number |
CTRI/2025/02/080367 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| 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
|
Effect of hip muscles strengthening exercise program on pain, strength and Q- Angle in active young adults with Patellofemoral pain syndrome. |
|
Scientific Title of Study
|
Biomechanical and Functional outcomes of a hip muscles strengthening exercise program in active young adults with Patellofemoral pain syndrome. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chhavi Vijay |
| Designation |
Masters of Physiotherapy (Ortho) |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab
Amritsar PUNJAB 143005 India |
| Phone |
6378664408 |
| Fax |
|
| Email |
misschhavi98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharnpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
GNDU |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab
Amritsar PUNJAB 143005 India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnpreet.pht@gndu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharnpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
GNDU |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab
Amritsar PUNJAB 143005 India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnpreet.pht@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chhavi Vijay |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab-143005 , India. |
| 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 Chhavi Vijay |
Health Centre of Guru Nanak Dev University |
Physiotherapy Department of Health Centre Amritsar PUNJAB |
6378664408
misschhavi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University, Amritsar - 143005 (India), (established by the State Legislature Act No. 21 of 1969) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Standing Hip rotation, Clamshells with resistance band, Lateral band walks, Fire hydrants and Semi prone Knee lifts. |
6 weeks protocol having 4 sessions per week. each session will be of 30 minutes duration. |
| Comparator Agent |
Strengthening of knee muscles, Stretching, Squats up to 45 degree. |
6 weeks protocol having 4 sessions per week, each session will be 30 minutes duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Pain located at the patellofemoral articulation for minimum of 2 months.
Pain is provoked with prolonged sitting and deep squatting.
Presence of observable dynamic knee valgus. |
|
| ExclusionCriteria |
| Details |
History or current report of knee ligament, tendon ot cartilage injury over a span of 1 year.
Traumatic patellar dislocation, patellar instability or prior patellar surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. KOOS-PF Questionnaire
2. Q-Angle
3. Single Leg Squat
4. Vertical Jump |
Outcome will be assessed at baseline, after 3 weeks and after 6 weeks of invention in both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
20/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/06/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 trial targets 18-30 year old physically active adults having patellofemoral pain syndrome. The subject will be approached and assessed for the inclusive and exclusive criteria then selected accordingly. A total of 52 participants will be randomly allocated in Group A (n= 26) and Group B (n= 26) using chit method. Group A will be given conservative treatment while Group B will receive hip muscles strengthening protocol. The treatment will be given for 6 weeks with 4 sessions per week. Each session has a time duration of 30 minutes. Outcome measures will be noted at the beginning and end of the entire treatment protocol. |