| CTRI Number |
CTRI/2024/10/075499 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of low back muscle activity in knee osteoarthritis patient. |
|
Scientific Title of Study
|
Activation of Lumbar Erector Spinae And Multifidus Muscles In Knee Osteoarthritius Patients : An Age And Gender Matched Electromyography 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 |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 202, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana MD Ali Jauhar Marg, Okhla, New Delhi - 110025, India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 202, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana MD Ali Jauhar Marg, Okhla, New Delhi - 110025, India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Kumar |
| Designation |
Student |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 207, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana MD Ali Jauhar Marg, Okhla, New Delhi - 110025, India
South
DELHI
110025
India |
| Phone |
8447398983 |
| Fax |
|
| Email |
sachinkumar230600@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, New Delhi, 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
|
|
|
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 |
Physiotherapy Clinic, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana MD Ali Jauhar Marg, Okhla, New Delhi - 110025, India
South
DELHI |
09958993486
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Knee osteoarthritis patient
Unilateral Knee Osteoarthritis
Knee osteoarthritis according to criteria of American College of Rheumatology
Morning Stiffness less than 30 minutes
Crepitus on active motion and Osteophytes
Bony Tenderness
No palpable warmth of synovium
NPRS between 3 to 6
BMI less than 30
Healthy individuals
All subjects with no musculoskeletal or neuromuscular disorders
Age and gender matched individual Age more than 50
No history of low back or knee pain
No history of hip or back injury or surgery |
|
| ExclusionCriteria |
| Details |
Patients with history of hip and/or back injury or surgery.
Past history of lower-limb joint replacement.
History of significant problems related to any other joint of upper limb, lower limb or
the spine.
Patients with lower limb vascular disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Root Mean Square (RMS) and Maximum Voluntary Isometric Contraction(MVIC) |
At day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The patients will be recruited from the community and the Centre for Physiotherapy and Rehabilitation Sciences (CPRS) clinic, Jamia Millia Islamia on the basis of the inclusion and exclusion criteria. Patients would be required to sign the consent form explaining their rights as research subjects. All the identifying information on the consent form and the demographic data shall be confidential. The assessment of the patient will include demographic data, anthropometric characteristics and screening for knee osteoarthritis. EMG measurements will be performed by a qualified physiotherapist. Using surface electromyography, onset amplitude of 2 muscles will be measured. Assessment will be done only once.
|