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

NCT ID: NCT04216147

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2019-01-31

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).

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

PNE

Intervention Type OTHER

Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.

Surgery group

Patients received surgery for median nerve release.

Group Type EXPERIMENTAL

Surgery for CTS

Intervention Type PROCEDURE

Median nerve release

Interventions

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PNE

Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.

Intervention Type OTHER

Surgery for CTS

Median nerve release

Intervention Type PROCEDURE

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..)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Jose Antonio Garcia Vidal

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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01/2014

Identifier Type: -

Identifier Source: org_study_id

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