Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis 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
- Intensity symptoms pre-intervention with a visual analogic scale
研究概览
简要总结
Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique.
The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a placebo.
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of carpal tunnel syndrome (low to moderate intensity) with a neurophysiological test.
Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the other placebo. Both groups receive 5 treatment sessions.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in placebo group, when the intervention finish the investigators will be given the opportunity to receive the actual technique
详细描述
The investigators selected patients diagnosed with carpal tunnel syndrome with electroneurogram, if they meet the inclusion criteria are offered to take part in this study.
When the patient agree to participate and signed informed consent, the investigators collected dependent variables considered (symptoms, mechanosensitivity, functional capacity with upper limb, tractor speed of neural conduction ...) and the patient is assigned to an intervention group: real or placebo. Each patient receives treatment 5 sessions trascurriendo intersessional 2- 5 days. After 5 sessions the investigators remeasured the same variables. In addition, a month later they remeasured again symptoms and functional capacity with upper limb. Finally, they were shown the technique they have received. If the patient has received the technical placebo he/she is given the opportunity to receive 5 sessions of the actual technique.
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
Intervention Goup
Actual Diacutaneous Fibrolysis
干预措施: Actual Diacutaneous Fibrolysis (Other)
Placebo Group
Sham Diacutaneous Fibrolysis
干预措施: Sham Diacutaneous Fibrolysis (Other)
结局指标
主要结局
Intensity symptoms pre-intervention with a visual analogic scale
时间窗: pre-intervention
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Intensity symptoms post-intervention with a visual analogic scale
时间窗: post-intervention
The investigators measure the intensity of symptoms with a visual analogic scale at the end of the intervention (2 weeks after pre-intervention) the investigators measured the intensity of symptoms (through study completion, an average 15 days)
Intensity symptoms after month with a visual analogic scale
时间窗: after month
The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.
次要结局
- Upper limb function pre-intervention with a validated questionnaire (DASH)(pre-intervention)
- Mechanosensitivity of median nerve pre-intervention with neurodynamic test(Pre-intervention)
- Mechanosensitivity of median nerve post-intervention with neurodynamic test(post-intervention)
- Neurophysiological test pre-intervention(pre-intervention)
- Neurophysiological test post-intervention(post-intervention)
- Upper limb function post-intervention with a validated questionnaire (DASH)(post-intervention)
- Upper limb function after month with a validated questionnaire (DASH)(after month)
研究者
Sandra Jiménez
Principal investigator
Universidad de Zaragoza