Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve 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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Percutaneous Electrical Nerve Stimulation; Procedure: Endoscopic surgery of the carpal tunnel

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alcorcon, Madrid
    • Alcorcon, Alcorcon, Madrid, Spain, 28922
      • César Fernández-de-las-Peñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Percutaneous Electrical Nerve Stimulation; 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.
ACTIVE_COMPARATOR: Surgery; 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.	Procedure: Endoscopic surgery of the carpal tunnel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain intensity between baseline and follow-up periods	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.	Baseline and 1, 3, 6 and 12 months after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hand function between baseline and follow-up periods	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.	Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in severity between baseline and follow-up periods	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.	Baseline and 1, 3, 6 and 12 months after the intervention.
Changes in patient self-perceived improvement between baseline and follow-up periods	. 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.	Baseline and 1, 3, 6 and 12 months after the intervention.

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: URJC0209201911819

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No