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Pain ModulationTENS vs PENSNCT07247721

Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) in people with Pain Modulation and Sensorimotor Function, run by University of Castilla-La Mancha at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSpain
Study dates
15 Jan 2026to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad de Castilla La Mancha

    Toledo, Toledo, 45071

Other trials in Spain

About this study

Official title: Comparison of the Effects of Transcutaneous vs. Percutaneous Electrical Nerve Stimulation on the Sensorimotor System of the Radial Nerve in Healthy Volunteers

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.

Read more

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.

Being tested
Transcutaneous Electrical Nerve Stimulation (TENS), Percutaneous Electrical Nerve Stimulation (PENS), Sham Transcutaneous Electrical Nerve Stimulation, Sham Percutaneous Electrical Nerve Stimulation
Keywords
Transcutaneous Electrical Nerve Stimulation, Percutaneous Electrical Nerve Stimulation, Low-Frequency Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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.

  • Sham Transcutaneous Electrical Nerve StimulationDevice

    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 Percutaneous Electrical Nerve StimulationDevice

    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.

Study groups in NCT07247721
Study groupRoleWhat they receive
Transcutaneous Electrical Nerve Stimulation (TENS)Active comparatorParticipants 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.
Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Percutaneous Electrical Nerve Stimulation (PENS)Active comparatorParticipants 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.
Receives: Device: Percutaneous Electrical Nerve Stimulation (PENS)
Sham TENSSham comparatorParticipants 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.
Receives: Device: Sham Transcutaneous Electrical Nerve Stimulation
Sham PENSSham comparatorParticipants 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.
Receives: Device: Sham Percutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately post-intervention

  2. 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.

    Measured: Baseline and immediately post-intervention

Secondary outcomes (1)
  1. Maximal Isometric Wrist Extensor Strength

    It will be assessed as an indirect measure of the blockade of motor fibers (Aα motoneurons) of the radial nerve. Maximal isometric wrist extensor strength will be measured using a hand-held dynamometer (MicroFET 2, Hoggan Scientific, USA) following Méndez-Rebolledo et al. protocol. Subject position: supine, shoulder at 0° abduction, elbow at 0° flexion, forearm fully pronated, and wrist at 30° flexion with fingers extended. Evaluator position: standing, thighs touching the table; upper hand stabilizes the forearm above the styloid processes, lower hand holds the dynamometer over the distal third of the metacarpals. Stabilization: provided by the upper hand. Adapter: large flat type. Dynamometer placement: over metacarpal heads. Execution: three maximal isometric contractions (kilogram-force (kgf)) of at least 5 seconds each, with 30 seconds rest between them. The mean of the three trials will be used as the final strength value.

    Measured: Baseline and immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start15 Jan 2026
  3. Primary completion15 Mar 2026
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07247721
Sponsor's protocol ID
GIFTO-TENSvsPENS-2025
Acronym
TENS vs PENS
Status last verified
Apr 2026
First submitted
15 Nov 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) in people with Pain Modulation and Sensorimotor Function, run by University of Castilla-La Mancha at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (PPT) (time frame: Baseline and immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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