| CTRI Number |
CTRI/2024/10/075821 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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
|
Effectiveness of Maitland Mobilization versus Conventional physiotherapy in Osteoarthritis of Knee Patients |
|
Scientific Title of Study
|
Effectiveness of Maitland Mobilization along with Conventional physiotherapy versus Conventional physiotherapy alone on the pain, function and Quality of life in Osteoarthritis of Knee
Patients: A Comparative 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 |
Apoorva Saxena |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
6350689145 |
| Fax |
|
| Email |
apoorva1996@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemendra Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopaedic Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9460888177 |
| Fax |
|
| Email |
drhksharma@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemendra Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopaedic Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9460888177 |
| Fax |
|
| Email |
drhksharma@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutuional Area, Sitapura, Tonk Road, Jaipur, Rajasthan (India), 302022 |
|
|
Primary Sponsor
|
| Name |
Apoorva Saxena |
| Address |
80/381, Pratap Nagar, Sanganer, Jaipur, Rajasthan (India), 302022 |
| 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 Hemendra Kumar Sharma |
Mahatma Gandhi Hospital, Jaipur |
Room no. 14
Physiotherapy OPD,
Basement
Jaipur
RAJASTHAN |
9460888177
drhksharma@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
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 |
| Comparator Agent |
Conventional Physiotherapy |
Conventional physiotherapy exercises-
1. Strengthening exercises- Static quadriceps exercise, Vastus Medialis Oblique exercises, Resisted quadriceps exercise, Hamstrings strengthening exercise, Hip abductors strengthening exercise.
Each contraction will be held for ten seconds followed by a 3 seconds rest and repeated ten times for 6 sessions in a week for the period of 4 weeks.
2. Stretching exercises- Calf stretching, Hamstring stretching.
Each stretch will be held for 30 secs and repeated three times for 6 sessions in a week for the period of 4 weeks.
3. Interferential therapy Frequency 4000 Hz, Base 90Hz, Sweep 40Hz, Beat Frequency 90 to130 Hz.
Interferential therapy will be given on painful area for 6 days in a week for initial 2 weeks. |
| Intervention |
Maitland Mobilization along with Conventional Physiotherapy |
Tibio femoral joint mobilization with Maitland method-
1. Distraction of the femur.
2. Posterior Tibiofemoral Glide (To enhance flexion).
3. Anterior Glide of the Tibio Femoral (To improve the extension).
4. Distal glide of the patellofemoral joint to maintain patellar mobility for normal knee flexion.
10 repetitions will be given per session with 30 seconds of rest will be given in between the sessions. Total 3 session in a week for the period of 4 weeks.
Conventional physiotherapy exercises-
1. Strengthening exercises- Static quadriceps exercise, Vastus Medialis Oblique exercises, Resisted quadriceps exercise, Hamstrings strengthening exercise, Hip abductors strengthening exercise.
Each contraction will be held for ten seconds followed by a 3 seconds rest and repeated ten times for 6 sessions in a week for the period of 4 weeks.
2. Stretching exercises- Calf stretching, Hamstring stretching.
Each stretch will be held for 30 secs and repeated three times for 6 sessions in a week for the period of 4 weeks.
3. Interferential therapy- Frequency 4000 Hz, Base 90Hz, Sweep 40Hz, Beat Frequency 90 to130 Hz.
Interferential therapy will be given on painful area for 6 days in a week for initial 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Kellgren and Lawrence grade 1 and 2 radiographic evidence of osteoarthritis
Knee osteoarthritis with duration ≥ 1 year
Subjects with knee pain
Subjects with Unilateral knee joint.
Subjects with Tibiofemoral knee joint
Patient with tightness in Quadriceps, Hamstring, and Iliotibial band |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis
Traumatic injury to knee joints within 6 months of study.
Any surgical intervention to the knee joints.
Intra-articular steroid injection in knee joints within 3months.
Subject with Psychiatric disorders/Illness.
Peripheral vascular disease.
Tumours/malignancies/infections associated with knee joint.
Neurological, cardiac and sensory problems. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale(NPRS)
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3. SF-36 |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale(NPRS)
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3. SF-36 |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
17/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/01/2025 |
|
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
|
Subjects of Group A will receive Maitland Mobilisation along with Conventional Physiotherapy Tibio femoral joint mobilization with Maitland method 1. Distraction of the femur 2. Posterior Tibiofemoral Glide (To enhance flexion) 3. Anterior Glide of the Tibio Femoral (To improve the extension) 4. Distal glide of
the patellofemoral joint to maintain patellar mobility for normal knee flexion Conventional physiotherapy exercises 1. Strengthening exercises Static quadriceps
exercise Vastus Medialis Oblique exercises Resisted quadriceps exercise Hamstrings strengthening exercise Hip abductors strengthening exercise 2. Stretching
exercises Calf stretching Hamstring stretching 3. Interferential therapy Frequency
4000 Hz Base 90Hz Sweep 40Hz Beat Frequency 90 to130 Hz Subjects of Group A will receive Conventional Physiotherapy Conventional physiotherapy exercises 1. Strengthening exercises Static quadriceps exercise Vastus Medialis Oblique exercises Resisted quadriceps exercise Hamstrings strengthening exercise Hip abductors strengthening exercise 2. Stretching exercises Calf stretching Hamstring stretching 3. Interferential therapy Frequency 4000 Hz Base 90Hz Sweep 40Hz Beat Frequency 90 to130 Hz |