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

NCT04216147 | Completed DMC

• 1 other identifier: 01/2014
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; nerve compression syndrome; median nerve; physical therapy technique; percutaneous needle electrolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale

  Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months

• Change of pain level

  Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months

• Change of Semmes Weinstein Mini monofilament kit

  Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months

• Change of the Hand Dynamometer

  Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months

• Changes of the Muscles strength by Kendall´s scale

  Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months

Other Outcomes (1)

• Direct and indirect health cost measures

  12 months after treatments

Study Arms (2)

PNE group

EXPERIMENTAL

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

Surgery group

EXPERIMENTAL

Patients received surgery for median nerve release.

Procedure: Surgery for CTS

Interventions

PNE OTHER

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

PNE group

Surgery for CTS PROCEDURE

Median nerve release

Surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years.
• CTS diagnosed by Electromyography (EMG)
• Symptoms of CTS + EMG

You may not qualify if:

• 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..)

Sponsors & Collaborators

• Universidad de Murcia: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Nerve Compression Syndromes

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: December 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 31, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share