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临床试验/NCT06590129
NCT06590129已完成不适用

Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Function

研究概览

简要总结

This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS.

详细描述

This prospective, longitudinal, randomized in two groups clinical study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS, evaluated initially and at 4 and 12 weeks.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •men and women ≥18 years of age,
  • •members referred to and treated at the Physical Medicine and Rehabilitation Service of HGR N°1, IMSS Mérida Yucatán, and who had a clinical or electrophysiological diagnosis of carpal tunnel syndrome.

排除标准

  • •included a clinical or electrophysiological diagnosis of radiculopathy, plexopathy, polyneuropathy, or other peripheral neuropathy;
  • •current diagnosis of cancer, coagulopathy, thoracic outlet syndrome;
  • •active infectious process or current fracture in the thoracic limb;
  • •previous surgery for carpal tunnel release;
  • •inability to cooperate with filling out scales, physical examination, or infiltration, as clearly detailed.

研究组 & 干预措施

Only Rehabilitation

Active Comparator

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then te patients were enroled to a 15-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

干预措施: Physiotherapy (Other)

Median nerve ultrasound guided hidrodissection + rehabilitation

Experimental

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed.

The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group.

干预措施: hydrodissection of median nerve (Procedure)

Median nerve ultrasound guided hidrodissection + rehabilitation

Experimental

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed.

The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group.

干预措施: Physiotherapy (Other)

结局指标

主要结局

Function

时间窗: Initially, 4 and 12 weeks.

Boston´s carpal tunnel questionnaire results, where each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function.

Pain

时间窗: Initially, 4 and 12 weeks.

Visual Analogue Scale (VAS) is a pain intensity measurement tool that uses a 10 cm line with two end points to indicate no pain and worst possible pain.

次要结局

未报告次要终点

研究者

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

Roberto Carlos Pech Arguelles

Director of Research

Instituto Mexicano del Seguro Social

研究点 (1)

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