Effectiveness of Trapeziometacarpal Splint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in pain scale
研究概览
简要总结
The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function
详细描述
Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm
排除标准
- •Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
- •Deformity of the distal interphalangeal joint (IFD) of the thumb
- •Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
- •Allergy to the material of the splint
- •Inability to respond to the questionnaire and perform the tests
- •Geographic inaccessibility
- •Infiltration in hand in the previous 3 months
- •Changes in the use of anti-inflammatory and analgesic past 3 months
- •Physiotherapy in hand over the last 3 months
- •Have the following related diseases: carpal tunnel syndrome, carpal fractures of DeQuervain syndrome, tendonitis, fibromyalgia and chronic inflammatory arthropathy.
结局指标
主要结局
Change in pain scale
时间窗: baseline, after 45, 90 and 180 days
次要结局
- Change in Functional capacity using the Cochin Hand Functional Scale questionnaire(baseline, after 45, 90 and 180 days)
- Change in pinch and grip strength(baseline, after 45, 90 and 180 days)
研究者
Fabiana de Carvalho Silva
Physiotherapist
Federal University of São Paulo