Clinical trial NCT05767788: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of pain in the Visual Analogue Scale (VAS)
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of pain in the Visual Analogue Scale (VAS)
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of pain in the Visual Analogue Scale (VAS)
timeFrame: The change before the start of treatment and 3-month after last treatment session
Secondary outcomes:
measure: Change of time used in the Timed Up and Go Test (TUG)
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of time used in the Timed Up and Go Test (TUG)
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of time used in the Timed Up and Go Test (TUG)
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of number of repetitions in the 30-second Chair Stand Test (30CST)
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of number of repetitions in the 30-second Chair Stand Test (30CST)
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of number of repetitions in the 30-second Chair Stand Test (30CST)
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of knee flexors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of knee flexors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of knee flexors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of knee extensors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of knee extensors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of knee extensors muscle strength by the hand-held dynamometer
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: The change before the start of treatment and 6-month after last treatment session
measure: Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: The change before the start of treatment and 6-month after last treatment session
measure: Change of active knee flexion range of motion by the standard goniometer
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of active knee flexion range of motion by the standard goniometer
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of active knee flexion range of motion by the standard goniometer
timeFrame: The change before the start of treatment and 3-month after last treatment session
measure: Change of active knee extension range of motion by the standard goniometer
timeFrame: The change before the start of treatment and after 6-week treatment
measure: Change of active knee extension range of motion by the standard goniometer
timeFrame: The change before the start of treatment and 1-month after last treatment session
measure: Change of active knee extension range of motion by the standard goniometer
timeFrame: The change before the start of treatment and 3-month after last treatment session
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: KING HIM CHAN, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: MING HON LEE, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: YIK SING SHUM, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: YEUK LAI CHAN, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: FADI AL ZOUBI, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: MAN HA TSANG, PhD
role: PRINCIPAL_INVESTIGATOR
References: