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临床试验/NCT07037069
NCT07037069进行中(未招募)不适用

Effectiveness of Desensitization Training vs Graded Motor Imagery Training on Wrist Pain and Function in Patients With Reflex Sympathetic Dystrophy

Superior University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

This study evaluated the effectiveness of two therapeutic approaches-Desensitization Training (DT) and Graded Motor Imagery (GMI)-in reducing wrist pain and improving function in patients with Reflex Sympathetic Dystrophy (RSD). The sample size was calculated using Epitools for one-way ANOVA comparison with two independent groups. A total of 40 participants were randomly assigned into two groups: the DT group and the GMI group, each consisting of 20 patients. The DT group underwent sessions involving progressive tactile stimulation using different textures and temperatures to reduce hypersensitivity and allodynia.

详细描述

In contrast, the GMI group followed a structured three-phase cognitive rehabilitation protocol including laterality recognition, explicit motor imagery, and mirror therapy, aimed at re-training cortical representation and reducing pain perception. Both groups received same number of sessions. Visual Analogue Scale (VAS), Patient Rated Wrist Evaluation (PRWE) & Specific Questionnaire for two groups is used to for pain and functional assessment involving wrist

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

入选标准

  • Participants aged 18 to 65 years.
  • Participants must have a confirmed diagnosis of Reflex Sympathetic Dystrophy (CRPS) Type I, affecting the wrist, according to the Budapest Criteria.
  • Participants must experience chronic wrist pain for at least 3 months but not more than 24 months.
  • Participants must be able to offer written informed consent and participate in the study willingly.
  • Participants must demonstrate sufficient cognitive function to understand the training protocols (assessed via screening tools such as the Mini-Mental State Examination).

排除标准

  • Participants who have undergone any surgical intervention for the wrist (other than the injury that led to RSD), or those with traumatic injuries that cause structural damage will be excluded.
  • Participants with significant neurological disorders affecting the upper limb.
  • Individuals with active psychiatric conditions, such as severe depression, anxiety, or psychosis which may impair participation in the study.
  • Participants with poorly controlled medical conditions such as diabetes, cardiovascular disease, or autoimmune disorders that could interfere with treatment outcomes or the ability to participate in the study.

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: 6 Month

A Visual Analogue Scale (VAS) is a measurement tool used to assess subjective characteristics, like pain intensity. It typically involves a 10 cm line with endpoints labeled "no pain" and "worst pain imaginable". The patient marks a point on the line that represents their pain level, and the score is determined by measuring the distance in millimeters (0-100) from the "no pain" end. VAS scores are commonly categorized as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Patient-Rated Wrist Evaluation (PRWE)

时间窗: 6 Months

The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to assess pain and functional disability in individuals with wrist problems. It consists of two modules: a pain module with 5 items and a function module with 10 items, each scored on a scale of 0 to 10. The PRWE provides a way for patients to self-report their experiences with wrist pain and its impact on their daily activities

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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