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NCT Number: NCT04246216

Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

There is evidence supporting that physical therapy interventions can be effective for the management of patients with CTS. No consensus on the best approach exist. It seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. The purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short- and long-term follow-up periods.

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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–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

César Fernández-de-las-Peñas

Alcorcón, Alcorcon, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pain and paresthesia in the median nerve distribution
  • positive Tinel sign,
  • positive Phalen sign,
  • symptoms had to have persisted for at least 6 months
  • deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy

Exclusion criteria

  • any sensory/motor deficit related to the ulnar or radial nerve;
  • older than 65 years of age;
  • previous surgical intervention, steroid injections or physical therapy intervention
  • multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
  • history of neck, shoulder, or upper limb trauma (whiplash);
  • history of any systemic disease causing CTS (eg, diabetes mellitus, thyroid disease);
  • history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
  • pregnancy;

Treatment and study plan

Percutaneous Electrical Nerve Stimulation

Procedure

Experimental: Percutaneous Electrical Nerve Stimulation The experimental group will receive 3 sessions (once per week) of ultrasound-guided Percutaneous Electrical Nerve Stimulation targeted the median nerve. Once the median nerve is ultrasound identified, the needles will be left in situ at the identified points connected to an electrostimulator (ES-160 ITO co.) applying a biphasic continuous waveform, at low frequency (2 Hz)19 and with 250 microseconds pulse duration for 30mins.

Endoscopic surgery of the carpal tunnel

Procedure

The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.

Primary outcomes

  1. Changes in pain intensity between baseline and follow-up periods

    Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.

    An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week.

Secondary outcomes

  1. Changes in hand function between baseline and follow-up periods

    Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.

    The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.

  2. Changes in severity between baseline and follow-up periods

    Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.

    The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.

  3. Changes in patient self-perceived improvement between baseline and follow-up periods

    Time frame: Baseline and 1, 3, 6 and 12 months after the intervention.

    . Subjects self-perceived improvement will be assessed using a Global Rating of Change (GROC) which consists of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). It has been reported that scores of +4 and +5 are indicative of moderate changes in patient status, whereas scores of +6 and +7 indicate large changes in the status of the patient.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2020
Registry last updated
Feb 8, 2023

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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