| CTRI Number |
CTRI/2023/12/060674 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of knee, hip and foot
strengthening exercises in knee pain |
|
Scientific Title of Study
|
Efficacy of Physiotherapy intervention in management of Patellofemoral pain syndrome: A Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalu Rani |
| Designation |
Research Scholar |
| Affiliation |
Department of physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar, Haryana (India)
Hisar
HARYANA
125001
India |
| Phone |
9812815343 |
| Fax |
|
| Email |
shalu.rani1387@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
manojmalikpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
manojmalikpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalu Rani Research Scholar Department of physiotherapy Guru Jambheshwar University of Science and Technology hisar-125001,Haryana (India ) |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
New Delhi-Sirsa Highway Hisar-125001, Haryana (India ) |
| Type of Sponsor |
Other [Government] |
|
|
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 |
| DrManoj Malik |
Guru Jambheshwar University of Science and Technology Hisar |
Room No: 109, Research Lab Department of Physiotherapy Hisar- 125001, Haryana (India)
Hisar
HARYANA |
9812815343
manojmalikpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of physiotherapy GJUST Hisar Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Group A will receive knee joint exercises for 3 weeks (4 times a week). |
| Intervention |
Group B |
Group B will receive knee and hip joint exercises for 3 weeks (4 times a week). |
| Intervention |
Group C |
Group C will receive knee joint exercise in combination of Diacutaneous fibrolysis for 3 weeks (4 times a week ). |
| Intervention |
Group D |
Group D will receive knee joint exercises and foot exercises for 3 weeks (4 times a week). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with anterior or retro patellar knee pain from at least 2 of the following activities regardless of the level of pain intensity: prolonged sitting, ascending and descending stairs, squatting, running, kneeling and hopping / jumping, Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks, Both males and females, Age group between 18 to 40 years, Presence of pain on palpation of patellar facets, Positive results in the physical examination tests: patellofemoral grinding test and patellofemoral compression test.
|
|
| ExclusionCriteria |
| Details |
Subjects with meniscal or other intra articular pathologic conditions, Subjects with cruciate or collateral ligament involvement, Subjects with patellar subluxation or dislocation, Subjects with previous surgery of the knee and hip joints, Subjects with knee and hip joints osteoarthritis, Pregnancy, Subjects with any conditions affecting the muscles strength like diabetes mellitus or rheumatoid arthritis, Non cooperative patients / participants not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain, Patellofemoral joint pain and disability, Tenderness around patella, PCD (Patella Condyle Distance)
|
The outcome measures will be evaluated at the baseline, at 3 weeks (end of treatment protocol) and followed up at 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/01/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 22-11-2023 and end date provided 22-12-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Patellofemoral pain syndrome is usually defined as pain around the patella that occurs during or after high-loaded knee flexion and extension accompanied by impaired function. There are studies that have individually explored the role of knee strengthening exercises, hip strengthening exercises, addition of hip and knee strengthening exercise, stretching of tight structures and found them to be effective in decreasing pain, improving strength and patellar maltracking. To our knowledge, till date no study has been published to find out the effect of combination of knee joint muscles exercises and DF technique. This research will help to design an adequate rehabilitation program for patient suffering from PFPS.
|