Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).

Official Title
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Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: PNE
* Procedure: Surgery for CTS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years. CTS diagnosed by Electromyography (EMG) Symptoms of CTS + EMG Exclusion Criteria: Difficulty expressing your feelings properly Unsurpassed fear of needles History of adverse reactions to needles Epilepsy and / or allergies to metals. Difficulty expressing your feelings properly Existence of diffuse peripheral neuropathy or cervical radiculopathy History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNE group<br>Patients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3). | Other: PNE<br>* Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.<br>|
| Experimental: Surgery group<br>Patients received surgery for median nerve release. | Procedure: Surgery for CTS<br>* Median nerve release<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Boston Questionnaire for Carpal Tunnel Syndrome | 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms) | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale | Describe the symptoms of the hand and wrist (pointing to them in a drawing), and using scales of 1 to 5 (1= No difficulty to do it; 5= I can´t do it), measure the difficulty of performing certain activities (writing, buttoning, holding a book ...) | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 
| Change of pain level | Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be) | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 
| Change of Semmes Weinstein Mini monofilament kit | Contact threshold, to assess if there is a decrease in sensitivity | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 
| Change of the Hand Dynamometer | Hand grip force | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 
| Changes of the Muscles strength by Kendall´s scale | Muscular strength of Opponens pollicis and Abductors policies. Scale of 0 to 5 (0=No visible or palpable contraction; 5=Full ROM against gravity, maximum resistance) | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 
| Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire) | 12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never) | Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel syndrome, nerve compression syndrome, median nerve, physical therapy technique, percutaneous needle electrolysis