Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain using VAS at rest in cm, strength (grip and pinch), activities of daily living using HAQ questionnaire, hand function using DASH questionnaire and satisfaction with use by a likert scale of five points (much worst to much better).
研究概览
简要总结
The purpose of the present study was to evaluate the effectiveness of a nighttime positioning hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb function, quality of life, and patient satisfaction. The hypothesis is that the stabilization of hand during nighttime could decrease pain and consequently improve quality of life.
详细描述
The involvment of wrist and fingers is very common in RA and it could affect hand function and, consequently, affect activities of daily living (ADL). Some authors suggest that the rest of hand could decrease pain and inflammation. Splints are external appliances that used in a specific body part provides the best alignment and rest in correct functional position. The goal of a hand, fingers and thumb in RA is stabilize the hand while the patients are not making theirs ADL and try to decrease the pain.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis classified according to the ACR criteria.
- •Use of the same remissive drugs for at least 6 months before the intervention and the same doses of the same corticosteroids and nonsteroidal anti-inflammatory drugs for at least one month before the study.
- •A score ≥ 3 and ≤ 7 on a visual analog scale (VAS) for pain in the more aching hand.
- •Agreement to participate in the study, and signing of a free informed consent form.
排除标准
- •Presented deformities in the more aching hand that did not permit fabrication of the splint.
- •Patients using any other type of upper limb splint.
- •Patients with a surgery scheduled within 6 months after the study.
- •Patients allergic to the splint material.
- •Patients with mental deficiency.
- •Patients who lived in inaccessible areas.
结局指标
主要结局
Pain using VAS at rest in cm, strength (grip and pinch), activities of daily living using HAQ questionnaire, hand function using DASH questionnaire and satisfaction with use by a likert scale of five points (much worst to much better).
时间窗: Three months
次要结局
未报告次要终点