Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve (TENS vs PENS)

University of Castilla-La Mancha

Status: Not yet enrolling

Conditions: Sensorimotor Function; Pain Modulation; Nerve Stimulation

Treatments: Device: Percutaneous Electrical Nerve Stimulation (PENS); Device: Sham Percutaneous Electrical Nerve Stimulation; Device: Sham Transcutaneous Electrical Nerve Stimulation; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07247721

GIFTO-TENSvsPENS-2025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Transcutaneous Electrical Nerve Stimulation (TENS)

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Percutaneous Electrical Nerve Stimulation (PENS)

Active Comparator group

Description:

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.

Treatment:

Device: Percutaneous Electrical Nerve Stimulation (PENS)

Sham TENS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcutaneous Electrical Nerve Stimulation

Sham PENS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Percutaneous Electrical Nerve Stimulation