Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Actual Diacutaneous Fibrolysis
Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.
干预措施: Diacutaneous Fibrolysis (Other)
Sham Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue
干预措施: Diacutaneous Fibrolysis (Other)
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
Cross sectional area of the median nerve with ultrasonography
时间窗: Baseline (Before the treatment)
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)
- Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)(Baseline (Before the treatment))
- Thicknesses of transverse carpal ligament with ultrasonography(Baseline (Before the treatment))
研究者
Sandra Jiménez
PhD Physiotherapist
Universidad de Zaragoza
