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

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).

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: PNE; Procedure: Surgery for CTS

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PNE group; 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; Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.
EXPERIMENTAL: Surgery group; Patients received surgery for median nerve release.	Procedure: Surgery for CTS; Median nerve release

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct and indirect health cost measures	Number of visits to the specialist, number of hospitalization days, number of physiotherapy sessions, prescribed medication, days of work absenteeism	12 months after treatments

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (ACTUAL): January 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; median nerve; nerve compression syndrome; physical therapy technique; percutaneous needle electrolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 01/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No