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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasonography

Intervention / Treatment
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* Other: Diacutaneous Fibrolysis


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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. | Other: 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: 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 | Other: 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross sectional area of the median nerve with ultrasonography | Cross sectional area of the median nerve with ultrasonography at carpal tunnel level | Baseline (Before the treatment) | 
| Cross sectional area of the median nerve with ultrasonography | Cross sectional area of the median nerve with ultrasonography at carpal tunnel level | After treatment application, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm) | Intensity of numbness with Visual Analogue Scale (1-10cm) | Baseline (Before the treatment) | 
| Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm) | Intensity of numbness with Visual Analogue Scale (1-10cm) | After treatment application, an average of 2 weeks | 
| Thicknesses of transverse carpal ligament with ultrasonography | the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level | Baseline (Before the treatment) | 
| Thicknesses of transverse carpal ligament with ultrasonography | the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level | After treatment application, an average of 2 weeks | 
| Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale) | Subjective assessment of clinical change with Global Rating of Change Scale (GROC scale) a scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better). | After treatment application, an average of 2 weeks |