Comparison of Two Carpometacarpal Stabilizing Splints for People With Thumb Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 6
- 主要终点
- Hand Function
研究概览
简要总结
Osteoarthritis (OA) of the thumb carpometacarpal (CMC) joint is a common condition that is seen regularly in outpatient occupational therapy and physiotherapy departments. Prevalence rates of symptomatic thumb OA have been found to be as high as 25%. The conservative treatment of choice consists of splinting. There are many different types of thumb splints available, but no specific guidelines as to which is preferred. There is limited evidence to support the benefits of splinting.
The purpose of this study is to compare the effectiveness of two different thumb splints: the Comfort Cool, a prefabricated neoprene splint and a custom made neoprene and thermoplastic thumb splint. These are two of the most commonly prescribed splints in local occupational therapy departments.
详细描述
Thumb (CMC) osteoarthritis is treated conservatively with splinting. The objectives of splinting the CMC joint include stabilizing the joint, reducing pain symptoms as well as enhancing performance of everyday activities. There is limited evidence to support the effectiveness of splinting in reducing pain and very little evidence to support the effectiveness of thumb splints to enhance function.
This CMC splint comparison study is a cross-over community based study of the effect of two different types of CMC stabilizing splints on patients with thumb OA. The objectives include measuring clients' OA symptoms and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN-HI 3.1), grip strength, pinch strength and client's personal splint preference on 4 separate occasions in order to compare the two thumb splints. The two splints differ in material and design. One splint is softer and incorporates more of the hand. The evidence gathered will support the effectiveness of specific splint design. It will also provide best practice guidelines for splint selection in clients with CMC OA.
We are using a one group own control cross-over design where outcome measures will be taken at week 1, week 4, week 5 and week 9. Each client will wear both splints for a 4 week period separated by a 1 week wash out period.
Procedure:
First appointment: At the initial visit the client will be randomly assigned to splint order. The client will complete the AUSCAN-HI 3.1, and a grip and pinch strength measurement. The first CMC stabilizing splint will be fabricated and fitted as per normal splinting treatment for clients with CMC OA. The client will be instructed how to wear and care for their splint. General instructions will include wearing the splint for symptomatic use as well as heavy activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician diagnosis of CMC OA
- •45 years or older
- •able to read and write in English
排除标准
- •previous thumb surgery
结局指标
主要结局
Hand Function
时间窗: 4 weeks
Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.
次要结局
- Pain(4 weeks)