Conservative Treatment for Hip Osteoarthritis: Effect of Manual Treatment and Hip School on Pain, Disability and Quality of Life - a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Pain: Numerical pain scale
研究概览
简要总结
The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.
详细描述
Hip osteoarthritis (hip OA) is the second most common arthritis of the larger joints and may result in pain and disability and lead to reduced quality of life (QoL). The prevalence of hip OA, in the adult population, > 35 years, is estimated to 4-11% in the western society. In specific countries hip OA affects up to 25% in adults > 60 years. With a growing elder population, these prevalence rates will increase and the demand for cost-effective and safe interventions will increase as well.
International guidelines, 2008, on the management of hip and knee OA recommend a combination of non-pharmacological and pharmacological treatment. For years the majority of interventional research for hip and knee OA has focused on surgery and drugs. Surgery is an option, when pain and disability have reached severe levels, and an increasing group of patients are today looking for other treatment options than drug treatment (pharmacological). In the last 4-6 years, new randomized controlled trials (RCT) have shown promising results with non-pharmacological treatment, such as exercise, patient education, manual therapy and acupuncture.
The purpose of this RCT is to investigate the effect of combining manual treatment and a patient education programme and compare it to a minimal intervention in form of a home stretching programme. It will further investigate the specific effect of manual treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients referred from general practitioner, chiropractor or orthopaedic surgeon
- •unilateral hip pain of minimum 3 months' duration
- •radiology criteria for hip OA: joint space width (JSW) < 2.0 mm or a side difference in JSW of > 10%
- •adequate mastering of the Danish language to complete instructions and questionnaires
排除标准
- •inflammatory joint disease
- •previous hip or knee alloplastic
- •secondary arthritis due to hip fracture or infection
- •bilateral hip pain
- •hip dysplasia with a CE angle > 25 degrees and an AA angle > 10 degrees
- •low back pain which dominates over the hip pain
- •malignant disease
- •patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease
- •hip pain resulting from labral tear, bursitis and/or snapping hip syndrome
- •polyarthritis
- •received manual treatment for the hip within the last year
结局指标
主要结局
Pain: Numerical pain scale
时间窗: Baseline, 6 weeks, 3 months, 1 year
次要结局
- Use of pain medication(Baseline, 6 weeks, 3 months, 1 year)
- Quality of life: EQ-5D(Baseline, 6 weeks, 3 months, 1 year)
- General improvement experienced by patient - "Global Assessment"(Baseline, 6 weeks, 3 months, 1 year)
- Passive hip range of motion(Baseline, 6 weeks, 3 months, 1 year)
- Patient Specific Hip Disability(Baseline, 6 weeks, 3 months, 1 year)
- Hip Disability and Osteoarthritis Outcome Score(Baseline, 6 weeks, 3 months, 1 year)
- Hip surgery up to one year after baseline(Baseline, 6 weeks, 3 months, 1 year)