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Completed

NCT Number: NCT04216147

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).

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..)

Treatment and study plan

PNE

Other

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

Surgery for CTS

Procedure

Median nerve release

Primary outcomes

  1. 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

  1. Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale

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

    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 ...)

  2. Change of pain level

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

    Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be)

  3. Change of Semmes Weinstein Mini monofilament kit

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

    Contact threshold, to assess if there is a decrease in sensitivity

  4. Change of the Hand Dynamometer

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

    Hand grip force

  5. Changes of the Muscles strength by Kendall´s scale

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

    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)

  6. Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)

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

    12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never)

Other outcomes

  1. Direct and indirect health cost measures

    Time frame: 12 months after treatments

    Number of visits to the specialist, number of hospitalization days, number of physiotherapy sessions, prescribed medication, days of work absenteeism

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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