Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Womac
研究概览
简要总结
Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is generally higher than that of coxarthrosis.
Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through either mobility or medication. Non-pharmacologic treatment is the first step, followed by the addition of analgesic medication, and ultimately by surgery.
The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function, which in turn both prevents formation of and delays progression of OA. A modification of conventional physiotherapy, whole body vibration has been successfully employed for several years. Since its introduction, this therapy is in wide use at our facility not only for gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.
详细描述
This study is a randomized, therapy-controlled trial in a primary care setting at a university hospital. Patients presenting to our outpatient clinic with initial symptoms of coxarthrosis will be assessed against inclusion and exclusion criteria. After patient consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises of one hour three times a week. Follow-up examinations will be performed immediately after treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20 patients will be included in each therapy group.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 - 80 years
- •Body weight less than or equal to 160 kg
- •Body-Mass-Index less than 40 kg/m²
- •Outpatient
- •Legal competence
- •Signed informed consent
- •Uni- or bilateral Coxarthrosis according to ACR criteria
- •WOMAC-pain index (visual analogue scale) of 30-70 mm
- •Coxarthrosis stage II-III according to Kellgren and Lawrence
排除标准
- •Participation in parallel interventional studies
- •Bilateral Coxarthrosis with WOMAC Pain index more than 70 mm
- •Previous surgery during the past 6 months at the Index Joint
- •Injury of the study joint during the last 6 months
- •Secondary rheumatoid or septic arthrosis or systemic diseases affecting the study joint
- •Activated coxarthrosis with intraarticular effusion
- •Body weight > 160 kg or body mass index > 40 kg/m²
- •Analgesic therapy with steroidal drugs
- •Physiotherapy of the lower extremities during the past 6 weeks
- •Existing endoprosthetics in the lower extremities
结局指标
主要结局
Changes in Womac
时间窗: 26 weeks
The primary outcome measure is the patients' evaluation of improvement on the visual analogue scale of the WOMAC indices for pain and activities of daily life, comparing baseline and post-treatment. The secondary outcome measures summarized in the appendices will also be assessed at baseline and after 6, 12, and 26 weeks
次要结局
- Leonardo Mechanography(26 weeks)
- SF-12(26 weeks)
研究者
Kourosh Zarghooni
Dr.med.
University of Cologne