| CTRI Number |
CTRI/2025/05/086343 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Movement With Mobilization for knee Osteoarthritis. |
|
Scientific Title of Study
|
Effectiveness of Mobilization with Movement (MWM) Along with Usual Care for Knee Osteoarthritis: A Randomized Clinical 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 |
Md Nazmul Huda |
| Designation |
Student |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Room no: 405, 4th floor, Physiotherapy department, Bangladesh Health Professions Institute (BHPI), Chapain, Savar, Dhaka.
1343
Other |
| Phone |
8801684835032 |
| Fax |
|
| Email |
piashnazmulhuda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Nazmul Huda |
| Designation |
Student |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Room no: 405, 4th floor, Physiotherapy department, Bangladesh Health Professions Institute (BHPI), Chapain, Savar, Dhaka.
1343
Other |
| Phone |
8801684835032 |
| Fax |
|
| Email |
piashnazmulhuda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadia Afrin Urme |
| Designation |
Lecturer |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Room no: 401, 4th floor, Physiotherapy department, Bangladesh Health Professions Institute (BHPI), Chapain, Savar, Dhaka.
1343
Other |
| Phone |
8801673722095 |
| Fax |
|
| Email |
nadiaurme41@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Md Nazmul Huda |
| Address |
Bangladesh Health Professions Institute (BHPI), Chapain Savar, Dhaka |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Nazmul Huda |
Muskuloskeletal Physiotherapy Unit, Physiotherapy department, CRP |
Room no: 405, 4th floor, Physiotherapy department, Bangladesh Health Professions Institute (BHPI), Chapain, Savar, Dhaka.
|
01684835032
piashnazmulhuda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of BHPI |
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 therapy |
Stretching exercise: 15-30 sec hold with 3-5 repetitions, 3 sets
Isometric exercise: 10 sec contraction with 10 repetitions, 3 sets
Eccentric exercise: 10 repetitions, 3 sets
Maitland mobilization: 10 repetitions, 3 sets
IRR or Ice: 10 minutes
|
| Intervention |
Movement With Mobilization (MWM) |
MWM consisted of a continuous manual movement of the tibia in various directions (medially, laterally, anteriorly, posteriorly, or rotated) while actively flexing and extending the knee. The approaches are comprehensively elucidated in a MWM textbook (Mulligan, 2004). Each patient was assessed in the supine position using sustained manual glides in all directions while actively flexing and extending their knees. Initially, an assessment was conducted on frontal plane glides, which was then followed by an evaluation of sagittal plane glides and rotation. The glide direction that resulted in the most significant decrease in discomfort and improvement in range of motion was selected as the glide for the MWM technique. If the range of motion (ROM) did not cause any pain, further pressure was applied at the conclusion. If the movement was not uncomfortable, an overpressure was applied at the end range. If the supine position did not cause any pain, the glide direction was then examined in the weight-bearing position. In order to determine the most effective glide direction, the tests that yielded identical results in the supine position were repeated in the weight-bearing position. The MWM treatment procedure was performed in a total of 10 repetitions, divided into three sets of three therapy sessions per week, over a period of 6 weeks (Takasaki, Hall & Jull, 2013).
Manual glide—non-weight-bearing—flexion and extension
• Lateral glide MWM for flexion (6–10 repetitions × 3–5 sets).
• Lateral glide MWM for extension (6–10 repetitions × 3–5 sets).
• Medial glide MWM for flexion (6–10 repetitions × 3–5 sets).
• Medial glide MWM for extension (6–10 repetitions × 3–5 sets).
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with knee OA who are diagnosed.
2. Age between 40 to 65 years (Koch, Sarma, Dutta, & Kalita, 2022).
3. Male and female both will be included (Alkhawajah, & Alshami, 2019).
4. Knee osteoarthritis affecting one or both knees, with a Kellgren and Lawrence grade of 2 or above (Kellgren, & Lawrence, 1957).
5. Patients undergoing physiotherapy at the musculoskeletal unit of CRP.
|
|
| ExclusionCriteria |
| Details |
1. Knee or lower limb surgery.
2. Injection of corticosteroid or hyaluronic acid into the joint during the last 6 months (Alkhawajah, & Alshami, 2019).
3. Neurological diseases.
4. The individual experiences modified feelings about cold, heat, or pressure in the area of their knee (Alkhawajah, & Alshami, 2019).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We used the Numerical Pain Rating Scale (NPRS) to measure pain intensity and a goniometer to measure joint angles. We use the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index to assess range of motion. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="0"
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)
|
15/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Introduction Osteoarthritis
(OA) is a common degenerative condition that primarily affects the knee joint.
Osteoarthritis is defined as the gradual degradation of the cartilage in the
joints, accompanied by changes in the bone underlying the cartilage, the
synovial fluid, the ligaments, and the muscles around the affected area. Common
manifestations of osteoarthritis (OA) include sensations of pain, stiffness,
and decreased physical movement. The estimated worldwide incidence of OA is
16.0%. The treatment known as mobilization with movement (MWM) reduces pain and
restores a full range of motion in the affected joint. Methods and analysis This study will be a randomized,
single-blind controlled trial. A total of fifty adult patients diagnosed with
knee osteoarthritis (OA) will be recruited. Participants will be randomly
assigned to receive either mobilization with movement (MWM) treatment or
conventional physiotherapy treatment. Outcome measures will include the
Numerical Pain Rating Scale (NPRS) for assessing pain intensity, a goniometer
for measuring joint range of motion, and the Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) for evaluating functional status.
Assessments will be conducted at baseline (pre-test) and after the intervention
(post-test). Ethics and
dissemination The Institutional Review Board (IRB) of Bangladesh
Health Professions Institute (BHPI) has approved the study. Every participant
will give their informed consent, and only authorized people will have access
to the anonymised data. The results of the study will be presented at
conferences and in peer-reviewed journals. |