Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis for VA Healthcare Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 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 find out how effective and feasible an 8-week course of Swedish massage is, for reducing pain and increasing function in adults who are VA healthcare users, with osteoarthritis (OA) of the knee.
详细描述
The goal of this supplement is to enroll n=25 VA healthcare users with knee OA into the initial 8-week EMBARK massage program in order to collect preliminary data on the feasibility, acceptability and efficacy of massage in this patient group, in preparation for a larger grant submission to evaluate the effectiveness of massage for knee OA in the VA healthcare system. All veterans enrolled under this supplement will complete the initial 8-week massage protocol, since this will allow us the maximum opportunity to assess the feasibility and gather preliminary efficacy data. Veterans with symptomatic knee OA will be recruited from the Durham VA Medical Center, and the remaining study activities will be completed at the Duke site of the EMBARK study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Be a veteran enrolled in care at the Durham VA Medical Center.
- •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 score in a specified 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 greater 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 (2004) or II (2009) 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, and 8 weeks
The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions. 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 and 8 weeks)
- Change in Pain: PROMIS Pain Interference Questionnaire(Baseline and 8 weeks)
- Change in Joint Flexibility(Baseline and 8 weeks)
- Change in Physical Function(Baseline and 8 weeks)