NCT01537484已完成不适用
Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 6
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
研究概览
简要总结
The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 years of age or greater.
- •Written confirmation of OA of the knee as provided by the participant's physician.
- •Radiographically-established OA of the knee.
- •Pre-randomization rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
- •Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
- •Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
- •American College of Rheumatology defined OA of the knee; specifically:
- •a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth
排除标准
- •Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
- •Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
- •Signs or history of kidney or liver failure.
- •Presence of asthma requiring the use of corticosteroid treatment.
- •Use of oral corticosteroids within the past four weeks.
- •Use of intra-articular knee depo-corticosteroids with the past three months.
- •Use of intra-articular hyaluronate with the past six months.
- •Arthroscopic surgery of the knee within the past year.
- •Significant injury to the knee within the past six months.
- •Presence of a rash or open wound over the knee.
- •Unable to satisfy the treatment and follow-up requirements.
- •Unable to provide written informed consent.
- •Currently receiving massage therapy on a regular basis (at least twice a month).
- •Knee replacement of study knee (ok if the knee not being studied has been replaced).
- •History of participating in the EMBARK Phase I or II studies.
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
时间窗: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions. WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy
次要结局
- Change in Pain: The Visual Analog Scale (VAS)(Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group))
- Change in Pain: PROMIS Pain Interference Questionnaire(Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group))
- Change in Joint Flexibility(Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group))
- Change in Physical Function(Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group))
研究者
研究点 (6)
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