Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve

NCT07247721 | Completed

• 1 other identifier: GIFTO-TENSvsPENS-2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of two types of electrical nerve stimulation techniques-Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS)-on the sensory and motor components of the radial nerve in healthy volunteers. Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, low-cost, and widely used electrotherapy technique that applies electrical currents through surface electrodes on the skin to relieve pain. Percutaneous Electrical Nerve Stimulation (PENS) is a minimally invasive technique that delivers the electrical current through fine needles inserted near a peripheral nerve, potentially producing stronger physiological effects. In this randomized, double-blind controlled clinical trial, 120 healthy participants aged 18-60 years will be randomly assigned to one of four groups: Transcutaneous Electrical Nerve Stimulation (TENS) Percutaneous Electrical Nerve Stimulation (PENS) Sham Transcutaneous Electrical Nerve Stimulation (TENS) (placebo) Sham Percutaneous Electrical Nerve Stimulation (placebo) Each participant will receive one 20-minute stimulation session. Outcomes will include: Pressure pain threshold (PPT) (measured with an algometer), Thermal pain threshold (measured with a thermode), Maximal Isometric wrist extensor strength (measured with a hand-held dynamometer). The goal is to determine whether Percutaneous Electrical Nerve Stimulation (PENS) produces greater changes in sensory and motor parameters than Transcutaneous Electrical Nerve Stimulation (TENS) and to evaluate differences compared to placebo. This research will improve understanding of the physiological effects of these commonly used electrotherapy modalities and support evidence-based decision-making in clinical practice.

Conditions

Nerve Stimulation; Pain Modulation; Sensorimotor Function

Keywords

Transcutaneous Electrical Nerve Stimulation; Percutaneous Electrical Nerve Stimulation; Low-Frequency Stimulation

Outcome Measures

Primary Outcomes (2)

• Pressure Pain Threshold (PPT)

  Description: It will be assessed as an indirect measure of the effect on the Aδ sensory fibers of the radial nerve. To record the mechanical pain threshold, a point will be marked on the dorsal surface of the trapeziometacarpal joint. A digital algometer with an increment scale of 0.1 Newtons (N) (Wagner Instruments, model FDIX) and a circular probe of 1 centimeter (cm) in diameter will be used. Once the probe is placed perpendicular to the skin, pressure will be increased at a rate of approximately 5 Newtons per second (N/s). Three measurements will be taken, with 15-second intervals between them, and the mean of the three values will be recorded as the pressure pain threshold. The reproducibility and reliability of pressure algometry to measure pressure pain threshold have been demonstrated in previous studies.

  Baseline and immediately post-intervention

• Thermal Pain Threshold

  Thermal pain threshold will be assessed as an indirect measure of the effect on unmyelinated C-type sensory fibers of the radial nerve. Hot stimuli will be applied to the dorsal area of the second metacarpal (radial nerve dermatome) using a 9 square centimeters (cm²) Peltier thermode (TSA 2, MEDOC, Israel). Three ascending temperature ramps will be performed with one-minute intervals. The heat pain threshold will be determined by the method of limits, and the average of the three measurements will be recorded. Baseline temperature: 32 degrees Celsius (°C); increase rate: 1 degree Celsius per second (°C/s); decrease rate: 3 °C/s. Participants will press a button with the contralateral hand when the heat becomes painful, triggering automatic cooling. For safety, a 50 °C cutoff temperature will be used. Prior to testing, a familiarization trial will be conducted on the dominant hand over the first and second metacarpals.

  Baseline and immediately post-intervention

Secondary Outcomes (1)

• Maximal Isometric Wrist Extensor Strength

  Baseline and immediately post-intervention

Other Outcomes (3)

• Adverse events

  immediately post-intervention

• Discomfort Rating (VAS)

  immediately post-intervention

• Blinding Effectiveness Questionnaire

  immediately post-intervention

Study Arms (4)

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

Participants will receive one session of Transcutaneous Electrical Nerve Stimulation (TENS) applied over the radial nerve using surface electrodes. Stimulation parameters: 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and intensity set at the individual tolerance threshold for 20 minutes.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Percutaneous Electrical Nerve Stimulation (PENS)

ACTIVE COMPARATOR

Participants will receive one session of Percutaneous Electrical Nerve Stimulation (PENS). A sterile 0.30 × 50 millimeter (mm) needle will be inserted near the radial nerve under ultrasound guidance. Stimulation parameters: 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and intensity set at the individual tolerance threshold for 20 minutes.

Device: Percutaneous Electrical Nerve Stimulation (PENS)

Sham TENS

SHAM COMPARATOR

Participants will undergo a sham Transcutaneous Electrical Nerve Stimulation (TENS) procedure identical in setup and duration to the active TENS group. Electrodes will be placed in the same positions, and the current intensity will be increased for about 30 seconds until a strong but comfortable tingling is felt, then gradually reduced to 0 milliamperes (mA). The electrodes will remain in place for 20 minutes to mimic the active procedure. Neither participants nor evaluators will have visual access to the device display. Participants will also receive a placebo needle intervention, consisting of a non-penetrating sham needle applied to the same anatomical region without skin insertion. This procedure mimics the sensation of needling but does not break the skin or produce physiological effects.

Device: Sham Transcutaneous Electrical Nerve Stimulation

Sham PENS

SHAM COMPARATOR

Participants will undergo a sham Percutaneous Electrical Nerve Stimulation (PENS) procedure. A real sterile acupuncture needle (0.30 × 50 millimeters (mm)) will be inserted at the same anatomical location used in the active PENS group, following the same ultrasound-guided procedure. The stimulator will remain switched off, following the same procedure used in the sham TENS group: the intensity will be increased for approximately 30 seconds until a comfortable tingling sensation is perceived and then gradually reduced to 0 milliamperes (mA), ensuring that no real stimulation is delivered. The needle will remain in place for 20 minutes to mimic the duration and setup of the active treatment.

Device: Sham Percutaneous Electrical Nerve Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Participants will receive one 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS) applied over the radial nerve of the non-dominant forearm. Two surface electrodes will be placed under ultrasound guidance (General Electric (GE) Logiq P9), longitudinally along the nerve path, approximately 5-8 centimeters (cm) proximal and distal to the lateral epicondyle. Stimulation parameters will consist of a biphasic symmetrical current at 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and an intensity adjusted to the maximum tolerable level without pain. The stimulator used will be an ENRAF NONIUS Endomed 484 (Madrid, Spain). Participants will remain in a supine position with the forearm supported in a prone posture. In addition, participants will receive a placebo needle intervention, consisting of a non-penetrating sham needle applied to the same anatomical region without skin insertion. This procedure mimics the sensation of needling but does not break the skin o

Transcutaneous Electrical Nerve Stimulation (TENS)

Percutaneous Electrical Nerve Stimulation (PENS) DEVICE

Participants will receive one 20-minute session of Percutaneous Electrical Nerve Stimulation (PENS) targeting the radial nerve of the non-dominant forearm. A sterile 0.30 × 50 millimeter (mm) acupuncture needle will be inserted under ultrasound guidance (General Electric (GE) Logiq P9, General Electric Healthcare, Milwaukee, WI, USA) approximately 1-2 mm from the radial nerve, at a depth of 2-3 centimeters (cm), avoiding direct contact. A surface electrode will be placed 2.5 cm distal and 1 cm cranial to the needle. Stimulation parameters: biphasic current, 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and intensity adjusted to the maximum tolerable level without pain. The stimulator used will be an ENRAF NONIUS Endomed 484 (Madrid, Spain). Participants will remain in a supine position with the forearm supported in a prone posture.

Percutaneous Electrical Nerve Stimulation (PENS)

Sham Transcutaneous Electrical Nerve Stimulation DEVICE

Participants will undergo a sham Transcutaneous Electrical Nerve Stimulation (TENS) procedure identical in setup and duration to the active TENS group. Two surface electrodes will be placed under ultrasound guidance (General Electric (GE) Logiq P9) along the nerve path, 5-8 cm proximal and distal, and the current will be increased for \~30 seconds until a strong but comfortable tingling is felt, then reduced to 0 milliamperes (mA). The electrodes will remain in place for 20 minutes to mimic the active procedure. The stimulator (ENRAF NONIUS Endomed 484) will remain on but deliver no current. Neither participants nor evaluators will have visual access to the device display to maintain blinding. Participants will also receive a placebo needle intervention, consisting of a non-penetrating sham needle applied to the same anatomical region without skin insertion. This procedure mimics the sensation of needling but does not break the skin or produce physiological effects.

Sham TENS

Sham Percutaneous Electrical Nerve Stimulation DEVICE

Participants will undergo a sham Percutaneous Electrical Nerve Stimulation (PENS) procedure identical in setup and duration to the active PENS group. A sterile needle (0.30 × 50 millimeters (mm)) will be inserted under ultrasound guidance (General Electric (GE) Logiq P9, General Electric Healthcare, Milwaukee, WI, USA) at the same anatomical site and depth as in the active PENS group. However, no electrical current will be applied. The stimulator (ENRAF NONIUS Endomed 484) will remain on but disconnected from the needle to maintain participant blinding. Neither participants nor evaluators will have visual access to the device screen. Total session duration: 20 minutes.

Sham PENS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between 18 and 60 years.
• No history of musculoskeletal or neurological disorders.
• No alterations in sensitivity in the upper limb.
• Not taking any medication in the previous two weeks.
• Able to understand the study procedures and provide informed consent.

You may not qualify if:

• Any neurological or neuromuscular disease.
• History of upper limb trauma, surgery, or persistent pain.
• Contraindications to electrical stimulation or invasive techniques.
• Presence of cardiac pacemaker, epilepsy, diabetes, cancer, or cardiovascular disease.
• Skin lesions or infections in the stimulation area.
• Pregnancy or suspected pregnancy.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Universidad de Castilla La Mancha

Toledo, Toledo, 45071, Spain

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Diego Serrano Muñoz, Universidad de Castilla-La Man

  Universidad de Castilla-La Mancha, Faculty of Physiotherapy and Nursing, Toledo, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 25, 2025
• Study Start: January 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)