Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Other: Actual Diacutaneous Fibrolysis
* Other: Sham Diacutaneous Fibrolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity) Exclusion Criteria: Severe carpal tunnel syndrome Previous surgery on the hand hormonal factors: diabetes, thyroids pathologies, pregnant cervical disfunctions ulcerations or skins disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Goup<br>Actual Diacutaneous Fibrolysis | Other: Actual Diacutaneous Fibrolysis<br>* 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.<br>|
| Sham Comparator: Placebo Group<br>Sham Diacutaneous Fibrolysis | Other: Sham Diacutaneous Fibrolysis<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity symptoms pre-intervention with a visual analogic scale | The investigators measure the intensity of symptoms with a visual analogic scale at baseline. | pre-intervention | 
| Intensity symptoms post-intervention with a visual analogic scale | 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) | post-intervention | 
| Intensity symptoms after month with a visual analogic scale | The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention. | after month | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carpal tunnel syndrome, physiotherapy, manual therapy