Effectiveness of Mobilization With Movement (MWM) on Patients With Knee Osteoarthritis (OA): A Double-blinded Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of pain in the Visual Analogue Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Movement with Mobilization (MWM)
Active movement with passive mobilization gliding force
干预措施: Movement with Mobilization (MWM) (Other)
Sham Movement with Mobilization (Sham MWM)
Active movement with passive light touch gliding force
干预措施: Sham Movement with Mobilization (Sham MWM) (Other)
结局指标
主要结局
Change of pain in the Visual Analogue Scale (VAS)
时间窗: The change before the start of treatment and 3-month after last treatment session
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)
时间窗: The change before the start of treatment and after 6-week treatment
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)
时间窗: The change before the start of treatment and 1-month after last treatment session
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.
次要结局
- Change of time used in the Timed Up and Go Test (TUG)(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)(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(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(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)(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)(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 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 change before the start of treatment and 3-month after last treatment session)
- Change of time used in the Timed Up and Go Test (TUG)(The change before the start of treatment and after 6-week treatment)
- Change of time used in the Timed Up and Go Test (TUG)(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)(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)(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(The change before the start of treatment and after 6-week treatment)
- Change of knee flexors muscle strength by the hand-held dynamometer(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(The change before the start of treatment and after 6-week treatment)
- Change of knee extensors muscle strength by the hand-held dynamometer(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)(The change before the start of treatment and after 6-week treatment)
- Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)(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)(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)(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)(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)(The change before the start of treatment and 3-month after last treatment session)
- Change of active knee flexion range of motion by the standard goniometer(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 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 change before the start of treatment and after 6-week treatment)
- Change of active knee extension range of motion by the standard goniometer(The change before the start of treatment and 1-month after last treatment session)