Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve

NCT ID: NCT07247721

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-04-15

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

Pain Modulation; Sensorimotor Function; Nerve Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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

Percutaneous Electrical Nerve Stimulation (PENS)

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Electrical Nerve Stimulation (PENS)

Intervention Type: 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.

Sham TENS

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.

Group Type: SHAM_COMPARATOR

Sham Transcutaneous Electrical Nerve Stimulation

Intervention Type: 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 PENS

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.

Group Type: SHAM_COMPARATOR

Sham Percutaneous Electrical Nerve Stimulation

Intervention Type: 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.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

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

Intervention Type: DEVICE

Percutaneous Electrical Nerve Stimulation (PENS)

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.

Intervention Type: DEVICE

Sham Transcutaneous Electrical Nerve Stimulation

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.

Intervention Type: DEVICE

Sham Percutaneous Electrical Nerve Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Serrano Muñoz, Universidad de Castilla-La Man

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Universidad de Castilla La Mancha

Toledo, Toledo, Spain

Countries

Spain

Central Contacts

Diego Serrano Muñoz, PhD

Role: CONTACT

diego.serrano@uclm.es

+34926051473

Jorge Sánchez-Infante Gómez-Escalonilla, PhD

Role: CONTACT

jorge.sanchezinfante@uclm.es

+34925 268 800

Facility Contacts

Diego Serrano Muñoz, PhD

Role: primary

diego.serrano@uclm.es

+34926051473

Other Identifiers

GIFTO-TENSvsPENS-2025

Identifier Type: -

Identifier Source: org_study_id