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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216147
• Other study ID #: 01/2014
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: December 2019
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 31, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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..)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Procedure:
• Surgery for CTS
Median nerve release

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change of the Hand Dynamometer	Hand grip force	Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Secondary	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
Secondary	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