Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Pain
研究概览
简要总结
Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.
详细描述
Objective
To evaluate the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.
Methods: Through a randomized controlled clinical trial with blind assessment and follow-up of six months. Fifty-Two participants were randomized into two groups: group orthosis and control, and made a night orthosis II and or III fingers, thermoplastic will be used as a treatment for participants orthosis group. The participants underwent four evaluations at time 0, 45 days, 90 days and 180 days after its inclusion in the study. The variables studied were: the visual analog scale of pain, grip and pinch strength, questionnaires Cochin and Australian/Canadian Hand Osteoarthritis Index and functional Pick-up test.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 40 and 80 years.
- •Patients diagnosed with osteoarthritis (OA) hand according to the American College of Rheumatology classification criteria.
- •Pain symptom in proximal interphalangeal (PIP's) or distal interphalangeal (DIP's) dominant hand in II and III or fingers.
- •Provide greater pain symptom of II and III or fingers between each other.
- •Complains of pain symptom measured by a visual analog scale (VAS) pain between 3 to 8 cm in the II and III or fingers of the dominant hand reported to perform joint movement (activity).
- •Thumb abduction with the II and III fingers without changing the pincer movement pulp-pulp.
排除标准
- •Other rheumatic diseases, neurological and skeletal muscle that can affect the upper limb.
- •Fibromyalgia uncontrolled.
- •Pregnancy.
- •Geographical inaccessibility and transport.
- •Cognitive impairment that prevents the understanding of assessment tools.
结局指标
主要结局
Change in Pain
时间窗: T0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)
Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm
次要结局
未报告次要终点
研究者
Paula Gabriel Silva
Principal Investigator
Federal University of São Paulo