Mobilization With Movement (MWM) on Knee Osteoarthritis (OA)

Study Overview
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Brief Summary
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Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA). However, immediate, and prolonged effects after prolonged MWM period was under-investigated. In this double-blinded randomized control trial, 40 patients are needed. The subjects and assessors will be blinded. Subjects in intervention group will receive MWM twice a week and corresponding home exercise for 6 weeks. Participants in control group will only receive sham treatment with light touch. The effects on knee pain in visual analogue scale (VAS); flexion and extension range of motion (ROM) by goniometer; strength by hand-held dynamometer; function by Timed Up and Go Test (TUG) and 30-second Chair Stand Test; and health-related quality of life (HRQoL) by Knee Injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) just after, 1-month and 3-month after treatment will be compared with baseline. Six-month after treatment, KOOS and WOMAC will be conducted.

Official Title
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Effectiveness of Mobilization With Movement (MWM) on Patients With Knee Osteoarthritis (OA): A Double-blinded Randomized Sham-controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Movement with Mobilization (MWM)
* Other: Sham Movement with Mobilization (Sham MWM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of knee OA for at least 1-year Pain intensity level ≥ 3 on a 10-cm Visual Analogue Scale (VAS) Both unilateral or bilateral knee pain Having morning stiffness less than 30 minutes Having crepitus on active movement Having bony tenderness Having bony enlargement Exclusion Criteria: Having active inflammatory or infectious knee conditions Having bone integrity conditions like osteoporosis Having knee joint instability Having skin integrity conditions like frail skin or lower limb peripheral vascular disease History of hip or knee fracture History of knee surgical history Use of knee corticosteroid or opioid injection

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Movement with Mobilization (MWM)<br>Active movement with passive mobilization gliding force | Other: Movement with Mobilization (MWM)<br>* Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.<br>|
| Sham Comparator: Sham Movement with Mobilization (Sham MWM)<br>Active movement with passive light touch gliding force | Other: Sham Movement with Mobilization (Sham MWM)<br>* Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior light-touch glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain in the Visual Analogue Scale (VAS) | Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked no pain and worst imaginable pain, at the time of assessment. | The change before the start of treatment and after 6-week treatment | 
| Change of pain in the Visual Analogue Scale (VAS) | Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked no pain and worst imaginable pain, at the time of assessment. | The change before the start of treatment and 1-month after last treatment session | 
| Change of pain in the Visual Analogue Scale (VAS) | Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked no pain and worst imaginable pain, at the time of assessment. | The change before the start of treatment and 3-month after last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of time used in the Timed Up and Go Test (TUG) | Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of time used in the Timed Up and Go Test (TUG) | Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of time used in the Timed Up and Go Test (TUG) | Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used. | The change before the start of treatment and 3-month after last treatment session | 
| Change of number of repetitions in the 30-second Chair Stand Test (30CST) | Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of number of repetitions in the 30-second Chair Stand Test (30CST) | Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of number of repetitions in the 30-second Chair Stand Test (30CST) | Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used. | The change before the start of treatment and 3-month after last treatment session | 
| Change of knee flexors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of knee flexors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of knee flexors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and 3-month after last treatment session | 
| Change of knee extensors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion and extension will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of knee extensors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion and extension will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of knee extensors muscle strength by the hand-held dynamometer | A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion and extension will be recorded respectively. An average of 3 testing trials will be used. | The change before the start of treatment and 3-month after last treatment session | 
| Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) | A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best). | The change before the start of treatment and after 6-week treatment | 
| Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) | A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best). | The change before the start of treatment and 1-month after last treatment session | 
| Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) | A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best). | The change before the start of treatment and 3-month after last treatment session | 
| Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) | A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best). | The change before the start of treatment and 6-month after last treatment session | 
| Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best). | The change before the start of treatment and after 6-week treatment | 
| Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best). | The change before the start of treatment and 1-month after last treatment session | 
| Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best). | The change before the start of treatment and 3-month after last treatment session | 
| Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best). | The change before the start of treatment and 6-month after last treatment session | 
| Change of active knee flexion range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of active knee flexion range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of active knee flexion range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and 3-month after last treatment session | 
| Change of active knee extension range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and after 6-week treatment | 
| Change of active knee extension range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and 1-month after last treatment session | 
| Change of active knee extension range of motion by the standard goniometer | The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine. An average of 3 testing trials will be used. | The change before the start of treatment and 3-month after last treatment session |