Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Federal University of São Paulo0 个研究点目标入组 40 人开始时间: 2005年7月1日最近更新: 2008年2月11日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 40
主要终点: Pain (VAS)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.

详细描述

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
•either gender;
•over 40 years of age;
•pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.

排除标准

•severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
•deformities of distal interphalangeal joint;
•use of a splint on the thumb in the previous six months;
•surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
•allergy to the splint material;
•incapacity to respond to the questionnaire and perform the tests;
•geographic inaccessibility;
•injections in the hand under study in the previous six months;
•other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy;
•alterations in the use of anti-inflammatory medication and analgesics in the previous three months.

结局指标

主要结局

Pain (VAS)

时间窗: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

次要结局

Function (DASH)(baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180))
Grip and pinch strength (dynamometer)(baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180))
Dexterity (O'Connor test)(baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180))

研究者

发起方

Federal University of São Paulo

申办方类型

Other

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