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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Movement with Mobilization (MWM); Other: Sham Movement with Mobilization (Sham MWM)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Movement with Mobilization (MWM); Active movement with passive mobilization gliding force	Other: Movement with Mobilization (MWM); 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.
Sham Comparator: Sham Movement with Mobilization (Sham MWM); Active movement with passive light touch gliding force	Other: Sham Movement with Mobilization (Sham MWM); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: KING HIM CHAN, BSc, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; Principal Investigator: MING HON LEE, BSc, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; Principal Investigator: YIK SING SHUM, BSc, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; Principal Investigator: YEUK LAI CHAN, BSc, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; Principal Investigator: FADI AL ZOUBI, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; Principal Investigator: MAN HA TSANG, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Anticipated): May 10, 2023
• Study Completion (Anticipated): May 10, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MWMKOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No