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临床试验/NCT05367817
NCT05367817已完成不适用

Effects of a Neuromuscular Joint Protective Exercise Therapy Program for Treatment of Wrist Osteoarthritis: a Randomized Controlled Trial

Region Skane1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
48
试验地点
1
主要终点
Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.

研究概览

简要总结

Individuals with wrist osteoarthritis (OA) can suffer from pain, muscular weakness, and impaired motion of the wrist, which can reduce the quality of life. While there is strong evidence that all patients with OA should receive first-line treatment with education and exercises, this approach has not yet been proposed for individuals with wrist OA. Therefore, this trial aimed to evaluate the effectiveness of a first line neuromuscular joint protective exercise therapy program compared to a training program with range of motion (ROM) exercises in patients with wrist OA.

详细描述

Background: Post-traumatic wrist OA develops slowly, and the joint degeneration may eventually lead to pain, muscular weakness, and stiffness of the wrist. As a result, this can affect the function of the entire upper limb, which can interfere with activities of daily living and the ability to work; thus, leading to reduced quality of life. A progress of disproportionate joint load and disturbed neuromuscular control are frequently present and may even make the condition worse.

Exercise therapy has been defined as a regime of physical activities designed and prescribed for precise therapeutic goals, aiming at educating the performance of specific exercises to improve neuromuscular control, reduce pain and achieve functional joint stability.

Self-management programs, including exercise therapy and joint protective strategies, are core treatments in knee and hip OA. Since the complex wrist joint cannot fully be compared to larger weight-bearing joints as the knee and hip, there is a need to develop exercise therapy programs specially designed for the wrist. Such a program should be part of a comprehensive joint protective standard care and could be beneficial to decrease disability and postpone, or possibly even eliminate, the need for surgery in individuals with wrist OA.

Aim: This is a randomized controlled trial (RCT) with the aim to investigate if a self-managed exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) will reduce pain and improve function more compared to a training program with range of motion (ROM) exercises (control group).

Material and methods: This study is a single-blinded randomized controlled trial (RCT) in patients with symptomatic and radiographically verified wrist OA with two treatment arms. The participants will be randomly assigned either to an exercise therapy program (intervention group) or to a training program including ROM exercises only. The participants in both groups will receive structured education on 1) wrist anatomy; 2) pathophysiology; 3) joint protective self-management strategies and 4) management of pain and fatigue by exercises.

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
Double (Participant, 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.

时间窗: Baseline, 3, 6 and 12 months

The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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