| CTRI Number |
CTRI/2021/12/038685 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Core Exercises on Pain and Function in Knee Osteoarthritis patients |
|
Scientific Title of Study
|
Effects of Core Stability Exercises on Pain and Physical Function in patients with Knee Osteoarthritis - A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Arun Ved |
| Designation |
Post Graduate Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Musculoskeletal Department, 2nd floor, room no 3, Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9757269027 |
| Fax |
|
| Email |
krishnaved06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD Musculoskeletal Department |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Musculoskeletal Department, 2nd floor, Room no 3, Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Arun Ved |
| Designation |
Post Graduate Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Musculoskeletal Department, 2nd floor, Room no 3, Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9757269027 |
| Fax |
|
| Email |
krishnaved06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sacheti Institute College of Physiotherapy, Musculoskeletal Department, 2nd floor, Room no 3, Thube Park, Pune |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune. |
| Type of Sponsor |
Private medical college |
|
|
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 Krishna Ved |
Sancheti Hospital - Institute for Orthopaedics and Rehabilitation |
Sancheti Hospital, Physiotherapy OPD, -1 (Basement), Room no 1, Shivajinagar, Pune.
Pune
MAHARASHTRA |
9757269027
krishnaved06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Stability Exercises in addition with Institutional Protocol |
Institutional + Core protocol for total 6 weeks, 2 sessions in the 1st week supervised in OPD and 10 supervised sessions in remaining 5 weeks through Tele-rehab
|
| Comparator Agent |
Institutional Protocol |
Institutional Protocol for total 6 weeks, 2 sessions in the 1st week supervised in OPD and 10 supervised sessions in remaining 5 weeks through Tele-rehab |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Osteoarthritis of knee by orthopedic doctor on radiographic and clinical findings
Grade I-III on Kellegren Lawrence Scale
Involvement - Unilateral/Bilateral |
|
| ExclusionCriteria |
| Details |
Patients with history of lower limb fracture, joint replacement or any surgery within prior 6 months
Presence of other conditions that may cause knee pain
Corticosteroid long use
Any other Cardiovascular, neurological and cognitive condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Timed Up and Go Test (TUG)
WOMAC Index (Modified-CRD Pune Version) |
Baseline and after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2021 |
| Date of Study Completion (India) |
20/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/07/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative study between 2 groups of patients with knee osteoarthritis, one group receiving Institutional Protocol alone and other group receiving Core Stability Exercises in addition with Institutional Protocol. Pre and Post intervention assessment will be done using Visual Analogue Scale, Timed Up and Go Test and WOMAC Index. |