Clinical Trial: Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome

Brief Summary:

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

Detailed Summary:

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.

Sponsor: Universidad de Zaragoza

Current Primary Outcome:

• Intensity symptoms pre-intervention with a visual analogic scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: after month ]
  The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Upper limb function pre-intervention with a validated questionnaire (DASH) [ Time Frame: pre-intervention ]
  The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
• Mechanosensitivity of median nerve pre-intervention with neurodynamic test [ Time Frame: Pre-intervention ]
  The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
• Mechanosensitivity of median nerve post-intervention with neurodynamic test [ Time Frame: post-intervention ]
  The investigators measure the mechanosensitivity of median nerve with neurodynamic test at the end of the intervention (through study completion, an average 15 days).
• Neurophysiological test pre-intervention [ Time Frame: pre-intervention ]
  The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
• Neurophysiological test post-intervention [ Time Frame: post-intervention ]
  The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at the end of the intervention (through study completion, an average 15 days)
• Upper limb function post-intervention with a validated questionnaire (DASH) [ Time Frame: post-intervention ]
  The investigators measure upper limb function with a validated questionnaire (DASH) at the end of the intervention (through study completion, an average 15 days)
• Upper limb function after month with a validated questionnaire (DASH) [ Time Frame: after month ]
  The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.

Original Secondary Outcome: Same as current

Information By: Universidad de Zaragoza

Dates:
Date Received: February 3, 2016
Date Started: October 2014
Date Completion:
Last Updated: October 25, 2016
Last Verified: February 2016