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

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Movement with Mobilization (MWM)
Sham Movement with Mobilization (Sham MWM)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Movement with Mobilization (MWM)

Sham Movement with Mobilization (Sham MWM)

Arm Description

Active movement with passive mobilization gliding force

Active movement with passive light touch gliding force

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 31, 2023
Last Updated
March 2, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05767788
Brief Title
Mobilization With Movement (MWM) on Knee Osteoarthritis (OA)
Official Title
Effectiveness of Mobilization With Movement (MWM) on Patients With Knee Osteoarthritis (OA): A Double-blinded Randomized Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Movement with Mobilization (MWM)
Arm Type
Experimental
Arm Description
Active movement with passive mobilization gliding force
Arm Title
Sham Movement with Mobilization (Sham MWM)
Arm Type
Sham Comparator
Arm Description
Active movement with passive light touch gliding force
Intervention Type
Other
Intervention Name(s)
Movement with Mobilization (MWM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Movement with Mobilization (Sham MWM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of pain in the Visual Analogue Scale (VAS)
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of pain in the Visual Analogue Scale (VAS)
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of pain in the Visual Analogue Scale (VAS)
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Secondary Outcome Measure Information:
Title
Change of time used in the Timed Up and Go Test (TUG)
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of time used in the Timed Up and Go Test (TUG)
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of time used in the Timed Up and Go Test (TUG)
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of knee flexors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of knee flexors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of knee flexors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of knee extensors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of knee extensors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of knee extensors muscle strength by the hand-held dynamometer
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Time Frame
The change before the start of treatment and 6-month after last treatment session
Title
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Time Frame
The change before the start of treatment and 6-month after last treatment session
Title
Change of active knee flexion range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of active knee flexion range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of active knee flexion range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session
Title
Change of active knee extension range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and after 6-week treatment
Title
Change of active knee extension range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and 1-month after last treatment session
Title
Change of active knee extension range of motion by the standard goniometer
Description
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.
Time Frame
The change before the start of treatment and 3-month after last treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KING HIM CHAN, BSc
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MING HON LEE, BSc
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YIK SING SHUM, BSc
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YEUK LAI CHAN, BSc
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FADI AL ZOUBI, PhD
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MAN HA TSANG, PhD
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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