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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Surgery for CTS; Other: PNE

• Registration Number: NCT04216147
• Lead Sponsor: Universidad de Murcia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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..)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery group	Surgery for CTS	Patients received surgery for median nerve release.
PNE group	PNE	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).

Primary Outcome Measures

Name	Time	Method
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	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)

Secondary Outcome Measures

Name	Time	Method
Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	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 ...)
Change of pain level	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be)
Change of Semmes Weinstein Mini monofilament kit	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	Contact threshold, to assess if there is a decrease in sensitivity
Change of the Hand Dynamometer	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	Hand grip force
Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never)
Changes of the Muscles strength by Kendall´s scale	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months	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)