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CTRI Number  CTRI/2024/12/078681 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Muscle ratio difference in knee pain vs no pain: a observational study 
Scientific Title of Study   Difference in Hamstring and Quadriceps recruitment ratio between knee pain subjects and Asymptomatic subjects: A cross-sectional observational 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  Ms Moneka C 
Designation  Under graduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  6379932549  
Fax    
Email  monekac03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Faculty of Physiotherapy, Room No 2.3, 2nd floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Ms Subameena A 
Designation  Under graduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  8939212274  
Fax    
Email  suba202003@gmail.com  
 
Source of Monetary or Material Support  
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai - 600116, Tamilnadu, India 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research  
Address  Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Soundararajan  Sri Ramachandra Institute of Higher Education and Research  Faculty of Physiotherapy, 2nd floor, room no 2.4, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Kancheepuram
TAMIL NADU 
9551163416

soundararajan.k@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Students project, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai - 600116, Tamilnadu, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Subjects identified with knee pain and asymptomatics
2 Age ≥18 years including both men and women
 
 
ExclusionCriteria 
Details  1 Known Inflammatory knee pathology
2 Subjects who had knee fracture or surgery
3 Subjects who have knee pain after trauma
4 If they are current or past smokers or tobacco chewers
5 Have participated in any exercise program in the past three months
6 Pain Score more than 4 in VAS  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Push pull Dynamometer  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
KOOS Questionnaire  At baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   07/01/2025 
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 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  

BACKGROUND

                  Knee pain is the second most common musculoskeletal condition in Indian population and it is the most frequent joint disease with the prevalence of 22% to 39% in India. Musculoskeletal conditions affecting the knee leads to pain and functional limitations. The knee function mainly depends on the balance between hamstring and quadriceps muscle recruitment. The present study is planned to assess the Hamstring and Quadriceps recruitment of patients with knee pain and to be compared with normal subjects, and to see whether there is any reduction in the strength of two muscle groups would result in a significant difference in the H:Q ratio.

AIM: 

The study aim is to compare the Hamstring and Quadriceps recruitment ratio between the knee pain subjects and asymptomatic subjects.

OBJECTIVE:

➢ To compare the difference in Hamstring and Quadriceps recruitment ratio in knee pain subjects and asymptomatic subjects by undergoing isometric muscle strength of Hamstring and Quadriceps using a Push-pull Dynamometer.

➢ The functional ability will be measured using the Knee Osteoarthritis Outcome

 Survey(KOOS).

➢ To find a relationship of functional ability between symptomatic knee pain subjects and asymptomatic subjects using KOOS

NEED FOR STUDY:

            Despite the importance of the H: Q ratio, there is limited research specifically comparing this ratio between knee pain patients and healthy individuals.  Knee pain may alter muscle recruitment patterns, affecting the balance between hamstrings and quadriceps. Investigating the specific differences in the H: Q ratio in pain patients could provide valuable insights.

PROCEDURE:

               Institutional Ethical Committee, SRIHER will be obtained and the Study will be registered in Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once participant fulfills inclusion criteria, informed consent will be obtained and all the baseline assessment will be done to the both knee pain subjects and asymptomatic subjects. The subjects will be assessed for isometric muscle strength with the hand-held dynamometer and then the range of motion will be assessed for both symptomatic and asymptomatic subjects. After the assessment the recruitment ratio of all subjects are noted and compared to know whether there is any reduction in the recruitment ratio of knee pain subjects compared to asymptomatic subjects.


 
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