| CTRI Number |
CTRI/2024/07/071011 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| 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
|
A clinical trial to study the effectiveness of mobilization with exercises versus pain education with exercises and exercises alone in patients with long standing knee pain |
|
Scientific Title of Study
|
Effect of Mulligans mobilization with movement versus biopsychosocial pain education along with exercises in individuals diagnosed with chronic osteoarthritis of knee - A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Makesh Babu |
| Designation |
Principal cum Professor |
| Affiliation |
Vedantaa Institute of Physiotherapy Sciences |
| Address |
Department of Physiotherapy
Vedantaa Institute of Physiotherapy Sciences,
Vedantaa Hospital and Research Center,
Village - Saswand,
Post - Dhundalwadi,
Taluk - Dahanu.
Thane
MAHARASHTRA
401606
India |
| Phone |
96333030701 |
| Fax |
|
| Email |
makeshmpt2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Preethi Rajesh |
| Designation |
Research Supervisor |
| Affiliation |
Garden City University |
| Address |
Assistant Professor,
School of Sciences,
Garden City University,
16th KM, Old Madras Road,
Bangalore, Karnataka,
India.
Bangalore
KARNATAKA
560049
India |
| Phone |
9845718613 |
| Fax |
|
| Email |
preethi.rajesh@gardencity.university |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Makesh Babu |
| Designation |
PhD Scholar |
| Affiliation |
Vedantaa Institute of Physiotherapy Sciences |
| Address |
Department of Physiotherapy
Vedantaa Institute of Physiotherapy Sciences,
Vedantaa Hospital and Research Center,
Village - Saswand,
Post - Dhundalwadi,
Taluk - Dahanu.
Thane
MAHARASHTRA
401606
India |
| Phone |
96333030701 |
| Fax |
|
| Email |
makeshmpt2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vedantaa Institute of Physiotherapy Sciences
Vedantaa Institute of Medical Sciences
Vedantaa Hospital & Research Center
Dahanu
Maharashtra-401606
India |
|
|
Primary Sponsor
|
| Name |
Makesh Babu |
| Address |
Department of Physiotherapy,
Room No.10,
Vedantaa Institute of Physiotherapy Sciences, Vedantaa Hospital and Research Center,
Village - Saswand,
Post - Dhundalwadi,
Taluk - Dahanu.
Maharashtra-401606.
India. |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DrMakesh Babu |
Vedantaa Institute of Medical Sciences |
Physiotherapy Department, Vedantaa Institute of Physiotherapy Sciences, Village - Saswand,
Post - Dhundalwadi,
Taluk - Dahanu.
Thane
MAHARASHTRA |
96333030701
makeshmpt2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vedantaa Institute of Medical Sciences- Institutional Ethics Committee |
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 |
Biopsychosocial Pain Education Group |
The subjects in Group B will receive Hot packs for 20 minutes as a standard care followed by 40 minutes with 10 minutes of Biopsychosocial pain education and 30 minutes of Exercise program.
An audio-visual aid that explains about the pain and Biopsychosocial pain education will focus on empowering the patient with knowledge of pain, biopsychosocial effects of pain, and how to manage pain with a changed behavioural approach on consecutive days and expected outcomes of physiotherapy management.
An exercise program includes Active Range of Motion and strengthening for hip, knee and ankle and also functional exercises that mimic activities of daily living will be given. 3 sets of 10 repetitions will be provided.
Each subject will be treated 1 session per day, 3 sessions in a week for 4 consecutive weeks. |
| Comparator Agent |
Exercise Group |
The subjects in Group C will receive Hot packs for 20 minutes as a standard care followed by the Exercise program.
The patients will be treated with Exercises and Hot packs as per the protocol in other groups.
An exercise program includes Active Range of Motion and strengthening for hip, knee and ankle and also functional exercises that mimic activities of daily living will be given. 3 sets of 10 repetitions will be provided.
Each subject will be treated 1 session per day, 3 sessions in a week for 4 consecutive weeks. Total duration of the treatment is 4 weeks. |
| Intervention |
Mulligans Mobilization with Movement |
The subjects in Group A will receive Hot packs for 20 minutes as a standard care followed by 40 minutes with 10 minutes of Mulligans Mobilization with Movement and 30 minutes of Exercise program.
Mulligans Mobilization with movement is a combination of sustained passive accessory joint mobilization with an active or functional movement.
Mulligans MWM consist of medial and lateral glide MWM and medial & lateral rotation MWM and in non-weight bearing and in weight-bearing position. 03 sets of 10 repetitions will be provided.
An exercise program includes Active Range of Motion and strengthening for hip, knee and ankle and also functional exercises that mimic activities of daily living will be given. 3 sets of 10 repetitions will be provided.
Each subject will be treated 01 session per day, 3 sessions in a week for 4 consecutive weeks. |
|
|
Inclusion Criteria
|
| Age From |
51.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the clinical criteria of the American College of Rheumatology for OA of Knee
2. Clinically and or radiologically diagnosed case of Grade 2 and 3 bicompartmental knee osteoarthritis according to the Kellgren and Lawrence classification
3. Unilateral or bilateral knee OA (most painful knee nominated by the patient will be considered)
4. Both genders will be included
5. Pain intensity of at least 4 cm on Numeric Pain Rating Scale (NPRS) and maximum of 7 during activity
6. B.M.I (Body Mass Index) - 18-30 Kg per m2
|
|
| ExclusionCriteria |
| Details |
1. Any history of trauma to the knees
2. Ligament injuries or neurological impairments
3. Previous knee or hip surgery
4. Fracture of lower extremity
5. Deformity of knee joint
6. Pain in the knee joint referred from another region
7. Rheumatoid arthritis
8. Severe cardiopulmonary disease
9. Uncontrolled hypertension and acute or terminal illness
10. Previous physiotherapy treatment for knee pain (previous 6 months)
11. Recent steroid injections in the knee joint (previous 3 months)
12. Peripheral Neuropathies
13. Peripheral vascular disease
14. Varicose vein
15. Osteoarthritis of Hip |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Numeric Pain Rating Scale (NPRS)
2) The Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC Scale)
3) Timed Up And Go Test (TUG) |
0 Weeks, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Range of Motion - Knee Flexion and Knee Extension
|
0 Weeks, 4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2"
Months="0"
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
|
Osteoarthritis (OA) of Knee is a
prevalent musculoskeletal condition affecting older people, producing pain,
physical disability, and reduced quality of life. OA is associated with
joint pain, functional limitation and deformity and it incurs articular cartilage
degeneration, osteophyte formation in joints, reduced joint space and
subchondral sclerosis. Patient with OA knee reported pain and difficulty
in everyday activities such as ascending and descending stairs, squatting,
kneeling, rising from a chair and getting in and out of a car.
OA of the knee can cause the muscles in the thighs to weaken, and this
weakness can make the joint feel unstable and could cause the knee to give way
when a person put weight on it. Quadriceps,
hamstrings, and hip muscles are significantly impaired in subjects with knee OA
compared with age-matched controls. Mobilization and exercises are
considered the most effective, non-drug treatment for reducing pain and
improving movement in patients with osteoarthritis.
This study aims to find out which
treatment technique will be effective in managing pain and disability, improving ROM and functional performance
among patients with chronic Osteoarthritis of Knee.
The patients will be selected for the
study based on the Inclusion and Exclusion criteria. Both male and female
patients diagnosed with chronic osteoarthritis of knee will be involved in the
study. Informed consent will be obtained from the patients
who meet the criteria after a detailed orientation by the primary researcher.
This study is a double blinded
randomized controlled trial. The participants in the Group A will receive
Mulligans Mobilization with Movement, Exercise program includes active range-of-motion (AROM) exercises and
strengthening exercises for the knee, hip and ankle, and functional exercises that mimic activities of
daily living will be given. Hot packs for
20 minutes will be provided as standard care. The time spent for each session
would be 60 minutes. One (01) session per day and 3 sessions per week
for 4 consecutive weeks will be provided. The participants in the Group B will
receive Biopsychosocial pain education, same Exercises mentioned in Group A and
Hot packs. Duration - 60 min per session, One (01) session per day and 3
sessions per week for 4 consecutive weeks will be provided. The participants in
the Group C will receive Exercises mentioned as in Group A and Hot packs. One
(01) session per day and 3 sessions per week for 4 consecutive weeks will be
provided.
Both primary and secondary outcome measures will
be taken before the first day of the intervention and immediately after the 4
weeks of intervention and after 1 month follow up period. |