Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Murcia
- Enrollment
- 140
- Primary Endpoint
- Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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..)
Arms & Interventions
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).
Intervention: PNE (Other)
Surgery group
Patients received surgery for median nerve release.
Intervention: Surgery for CTS (Procedure)
Outcomes
Primary Outcomes
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
Time Frame: 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 Outcomes
- Change of Semmes Weinstein Mini monofilament kit(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- 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 the Hand Dynamometer(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)(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)
Investigators
Jose Antonio Garcia Vidal
Doctor
Universidad de Murcia