| CTRI Number |
CTRI/2024/04/065543 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Hip Abductor Versus Hip Adductor Strengthening Exercise on Pain, Muscle Strength and Functional Outcome in Primary Tibiofemoral Osteoarthritis of Knee. |
|
Scientific Title of Study
|
Effects of Hip Abductor Versus Hip Adductor Strengthening Exercise on Pain, Muscle Strength and Functional Outcome in Primary Tibiofemoral Osteoarthritis of Knee. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balaji M |
| Designation |
MPT Orthopaedic Student |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Orthopaedics Department of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9597490413 |
| Fax |
|
| Email |
gauthambalaji05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof V S Seetharaman |
| Designation |
Principal |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Orthopaedics Department of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
principal@sriramakrishnacollegeofphysiotherapy.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof V S Seetharaman |
| Designation |
Principal |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Orthopaedics Department of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
principal@sriramakrishnacollegeofphysiotherapy.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Orthopaedics Department of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore |
|
|
Primary Sponsor
|
| Name |
Balaji M |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Orthopaedics Department of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Balaji M |
Sri Ramakrishna Multi Speciality Hospital |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017
Division of Orthopaedics Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Pin 641044
Coimbatore
TAMIL NADU |
9597490413
gauthambalaji05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital Ethical Committee |
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 |
Hip Abductor Strengthening
|
40 minutes of treatment duration weekly twice every 3rd day for 6 Weeks 12 sessions for each subjects. |
| Comparator Agent |
Hip Adductor Strengthening |
40 minutes of treatment duration weekly twice every 3rd day for 6 Weeks 12 sessions for each subjects. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Tibiofemoral OA unilateral
Mild and Moderate grade according to kellgren and Lawrence scale
Knee pain VAS more than 5 |
|
| ExclusionCriteria |
| Details |
Subjects with any neurological or cardiorespiratory conditions and any psychological Problems.
Any recent knee injuries
Any previous Lower limb surgeries
Patellofemoral OA
Any Deformities of Lower Limb and Recent Lower Limb Fractures
Chondromalacia patella, Ligament and Menisci repair. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Muscle strength
Functional outcome
|
At baseline and after 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
EFFECTS OF HIP ABDUCTOR VERSUS HIP ADDUCTOR STRENGTHENING EXERCISES ON PAIN, MUSCLE STRENGTH AND FUNCTIONAL OUTCOME IN PRIMARY TIBIOFEMORAL OSTEOARTHRITIS OF KNEE.
ABSTRACT
Background: Global statistics reveals over 100 million people worldwide suffer from OA, which is one of the most common causes of disability. The World Health Organization forecasted that osteoarthritis will become the fourth primary cause of disability by the year 2020. The symptoms of knee OA include pain, joint stiffness and reduced quadriceps strength, causing physical disability.
Objective: The objective of this study is to evaluate the effects of Hip abductors versus Hip adductors strengthening exercise on pain, muscle strength and functional outcome in primary tibiofemoral OA Knee.
Methods: It is an interventional study, total 30 subjects with primary tibiofemoral OA knee were selected according to inclusion and exclusion criteria. They will be divided into two groups A and B . They perform exercise for 6 weeks . The pre and post effects of intervention was measured by visual analog scale, Digital hand held dynamometer and KOOS questionnaire.
Result: Statistical analysis will be done after data collection and conclusion would be drawn.
Keywords: Tibiofemoral OA knee, Hip muscle strengthening, Pain, Muscle Strength, Functional outcome.
|