| CTRI Number |
CTRI/2024/04/065410 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of Patellofemoral Pain Syndrome in Runners |
|
Scientific Title of Study
|
Assessment and Prediction of Risk Factors Contributing to Patellofemoral Pain Syndrome in Runners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bishnu Ghale |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q block room no. QT-07, Biomechanics and kinesiology lab, Physiotherapy Department MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
7906229734 |
| Fax |
|
| Email |
bishu66g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q block, room no QS-06, Physiotherapy Department MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
jasminekaur.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q block, room no QS-06, Physiotherapy Department MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
jasminekaur.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sports Injury Centre, Safdarjung Hospital, New Delhi and Manav Rachna International Institute of Research and Studies, Faridabad |
|
|
Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad |
| Type of Sponsor |
Other [University ] |
|
|
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 Bishnu Ghale |
Safdarjung Hospital |
Sports Injury Centre, Second Floor, Room 128, Biofeedback room, Ansari Nagar West, New Delhi
New Delhi
DELHI |
7906229734
bishu66g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Comittee, Allied Health Sciences, MRIIRS and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
History of Patellofemoral pain syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Long-distance runners both male and female
Training for not less than 6 months
Patellofemoral pain syndrome patient
Athletes who are comprehend with English language
|
|
| ExclusionCriteria |
| Details |
Any other musculoskeletal pathology affecting their lower leg in the last six months
History of any lower limb fracture in the last six months
Any surgery in the lower limb in the last 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Identify and analyze the anatomical and biomechanical risk factors associated with Patellofemoral pain syndrome in runners.
To identify association of the functional limitations with anterior knee pain in runners.
|
Total duration of study is 52 weeks. In 32 weeks 64 athletes will be assessed for any anatomical, biomechanical risk factors and functional limitations associated with Patellofemoral pain syndrome in runners |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of Prediction factors & development of prediction equation of PFPS in athletic runners |
In 20 weeks statistical analysis will be done based on which equation will be derived to predict the risk of patellofemoral pain syndrome |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="145" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
Modification(s)
|
Subjects will be assessed for previous history of Patellofemoral pain syndrome and will be randomised into 2 groups: Previously Injured Group and Uninjured group. Subjects will be informed of the purpose of the study and to read and signed an informed consent form. A Functional questionnaire and self made questionnaire must be filled by the subjects prior to testing. At the end of the study a prediction equation will be derived based on the statistical analysis to predict risk factors of developing patellofemoral pain syndrome (PFPS). |