| CTRI Number |
CTRI/2025/05/087726 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Maitland Mobilization and Myofascial Release Technique in knee Osteoarthritis: A randomized controlled trial. |
|
Scientific Title of Study
|
Efficacy of Maitland Mobilization and Myofascial Release Technique in patients with Knee Osteoarthritis: 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 |
POOJA KUMARI |
| Designation |
MPT MUSCULOSKELETAL STUDENT |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmai marg, New Delhi-110019
South
DELHI
110019
India |
| Phone |
9123107764 |
| Fax |
|
| Email |
poojakri26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHANCHAL JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmai marg, New Delhi-110019
South
DELHI
110019
India |
| Phone |
9810648719 |
| Fax |
|
| Email |
chanchal@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHANCHAL JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmai marg, New Delhi-110019
South
DELHI
110019
India |
| Phone |
9810648719 |
| Fax |
|
| Email |
chanchal@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institute of Physiotherapy, Chandiwala Estate, Maa Anandmai Marg, New Delhi-110019, India |
|
|
Primary Sponsor
|
| Name |
POOJA KUMARI |
| Address |
Chandiwala Estate, Maa Anandmai Marg, New Delhi-110019, India |
| 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 |
| Dr CHANCHAL JAIN |
Banarsidas Chandiwala Institute of Physiotherapy |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmai Marg, New Delhi-110019
South
DELHI |
9810648719
chanchal@bcip.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of Banarsidas Chandiwala Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Intervention will be given on an alternate day basis for 2 weeks with daily home exercise program. |
| Intervention |
Maitland Mobilization and Myofascial Release Technique |
Intervention will be given on an alternate day basis for 2 weeks with daily home exercise program. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male and females from the age group of 40-70 years.
Diagnosed with Knee Osteoarthritis-Physician/Orthopaedician diagnosed.
Medically diagnosed with Knee OA grade 1 and 2 according to Kellgren-Lawrence grading scale.
Subjects with pain on Patellofemoral compression, crepitus, periarticular/joint line tenderness, swelling, limited range of motion on baseline assessment.
Subjects with unilateral/bilateral knee OA. |
|
| ExclusionCriteria |
| Details |
Surgical procedures/injury.
Co-existing neurological condition.
Osteoporosis, systemic illness and metabolic disorder.
Dermatological diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Universal Goniometer (Range of Motion) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale
WOMAC scale
TAMPA scale of Kinesiophobia |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/08/2025 |
| 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
|
Knee Osteoarthritis is the most common joint disease causing disability. Degeneration of cartilages and reduced joint space leads to pain and dysfunction. This study focuses on use of two techniques to improve knee osteoarthritis. Mobilization helps in restoring range of motion by decreasing the progression of narrowing of joint space, whereas MFR helps with loosening the taut band, improving circulation and decreasing pain.
This study aims to compare the combined effect of Maitland’s mobilization and MFR to the existing conventional physiotherapy for knee Osteoarthritis.
Sample size: 36
Group A: n=18: MAITLAND MOBILIZATION AND MYOFASCIAL RELEASE TECHNIQUE:
Maitland’s mobilization grades 1 and 2 will be given for pain and grades 3 and 4 will be given to increase the range of motion, 2-6 bouts of 30sec, per manual technique will be given. Glides included are: Tibiofemoral distraction, Tibiofemoral Anterior Glide, Tibiofemoral posterior glide, Patellofemoral glides. Myofascial release technique will be applied on IT band, hamstring and quadriceps muscles. Every stroke is to be held for 30 seconds, 5 repetitions per session.
Group B: n=18: CONVENTIONAL THERAPY:
Thermotherapy Electrotherapy(TENS) Strengthening exercises (static and dynamic quadriceps, static hamstring contraction, VMO) Stretching exercises (Stretching of quadriceps, hamstrings and calf muscles) Ergonomics. |