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CTRI Number  CTRI/2023/03/051226 [Registered on: 31/03/2023] Trial Registered Prospectively
Last Modified On: 30/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Muscle activity of Quadriceps and Gluteus Medius during functional activity in Patellofemoral pain syndrome 
Scientific Title of Study   Activation pattern of Quadriceps and Gluteus Medius at multiple knee joint angles in Patellofemoral pain syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zubia Veqar 
Designation  Associate Professor 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Zubia Veqar 
Designation  Associate Professor 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Public Query  
Name  ARSHIYA FAIZ 
Designation  STUDENT 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi

South
DELHI
110025
India 
Phone  9873255859  
Fax    
Email  arshiyafaiz786@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi- 110025, India 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi- 110025, India 
Type of Sponsor  Other [Central University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr zubia Veqar  jamia Millia Islamia and Delhi NCR  Room no 202, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi- 110025, India South DELHI
South
DELHI 		 9958993486

veqar.zubia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jamia Millia Islamia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  For PFPS group.
1.Anterior or retropatellar knee pain on at least two of the following activities-
prolonged sitting with the knee bent, ascending or descending stairs or sloped surfaces, squatting, running, kneeling, and hopping/jumping
2.Average pain level of 3 or more on a 10 on NPRS scale.
3.An insidious onset of symptoms unrelated to a traumatic incident.
4.All participants were aged 18-35 years.
5.Anterior knee pain longer that 6 months.
6.Positive patella compression test and tenderness around patella.
7.Anterior knee pain scale should be 80 or lower on Kujala score
8.If Bilateral PFPS is present than dominant leg will be tested.

For healthy individuals
1.No pain in the knees
2.Never had significant knee or lower extremity pathology or surgery
3.No difficulty in functional activities like squatting, prolonged sitting, ascending and descending stairs or sloped surfaces, squatting, running, kneeling and hopping/jumping
4.Dominant limb will be tested
 
 
ExclusionCriteria 
Details  1.A recent history (within 3 months) of knee surgery,
2.A history of patellar dislocation/subluxation, or clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis, or referred pain from the spine
3.Acute inflammation with knee joint effusion

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Electromyography
Electrogoniometer 		 BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   N/A 
Date of First Enrollment (India)   03/04/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NO 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Subjects will be recruited from CPRS clinic, Jamia Millia Islamia and community on the basis of inclusion and exclusion criteria, and informed about the study. Subject will be explained the purpose and the possible risks of the study. They will be given an informed consent from explaining their rights as research subjects. They will be divided into two groups, one is experimental group that includes patients with PFPS on the basis of inclusion criteria and the other is control group that include healthy young collegiates. In both the groups, the electromyographic activity (EMG) of the VMO, VL and G Medius muscles will be analyzed at multiple knee joint angles by using Electrogoniometer while performing squatting, ascending and descending stairs. All identifying information on the consent form and demographic data will be kept confidential.

 
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