| 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
|
|
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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
|
|
|
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 ab ility 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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