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临床试验/NCT04762238
NCT04762238已完成不适用

Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?

Universidad de Zaragoza2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Cross sectional area of the median nerve with ultrasonography

研究概览

简要总结

The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible to all clinicians. In this way ultrasounds (US) is a more accessible and economical tool and many studies have reported that US has high sensitivity and specificity in the diagnosis of CTS.Diacutaneous Fibrolysis (DF) is a physiotherapeutic technique derived from Cyriax deep friction massage principles.DF technique could assist in improving changes in the connective tissues adjacent to the median nerve, especially the thickness of TCL and this could be reflected in a decreasing of TCL. Moreover, the neurophysiological and mechanical effect described by this technique may improve the nerve compression decreasing the CSA of the median nerve.

The purpose of this study is to quantify changes in the cross-sectional area of the median nerve in the carpal tunnel and the thickness of transversal carpal ligament measured by US and the changes in the intensity of the numbness and the subjective assessment of clinical change after DF treatment in forearm, wrist and hand area compared to placebo.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)

排除标准

  • Severe carpal tunnel syndrome
  • Previous surgery on the hand
  • hormonal factors: diabetes, thyroids pathologies, pregnant
  • Cervical disfunctions
  • Ulcerations or skins disorders

结局指标

主要结局

Cross sectional area of the median nerve with ultrasonography

时间窗: After treatment application, an average of 2 weeks

Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

次要结局

  • Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)(After treatment application, an average of 2 weeks)
  • Thicknesses of transverse carpal ligament with ultrasonography(After treatment application, an average of 2 weeks)
  • Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)(After treatment application, an average of 2 weeks)

研究者

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

Sandra Jiménez

PhD Physiotherapist

Universidad de Zaragoza

研究点 (2)

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