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.
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
- Conditions the study is for
- Pain Modulation, Sensorimotor Function, Nerve Stimulation
- 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.
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.
- Conditions
- Pain Modulation, Sensorimotor Function, Nerve Stimulation
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Sham Percutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted25 Nov 2025
- Study start15 Jan 2026
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ModulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Serrano Muñoz, Universidad de Castilla-La Man, Principal investigator, Universidad de Castilla-La Mancha, Faculty of Physiotherapy and Nursing, Toledo, Spain
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Transcutaneous vs. Percutaneous Electrical Nerve Stimulation on the Sensorimotor System of the Radial Nerve in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07247721
- Acronym / sponsor ID
- TENS vs PENS / GIFTO-TENSvsPENS-2025
- Conditions
- Pain Modulation, Sensorimotor Function, Nerve Stimulation
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Percutaneous Electrical Nerve Stimulation, Low-Frequency Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Active comparator | Device: 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. |
| Percutaneous Electrical Nerve Stimulation (PENS) | Active comparator | Device: 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. |
| Sham TENS | Sham comparator | Device: Sham Transcutaneous Electrical Nerve StimulationParticipants 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. |
| Sham PENS | Sham comparator | Device: Sham Percutaneous Electrical Nerve StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Transcutaneous Electrical Nerve Stimulation (TENS) |
| 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. | Device | Percutaneous Electrical Nerve Stimulation (PENS) |
| Sham Transcutaneous Electrical Nerve StimulationParticipants 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. | Device | Sham TENS |
| Sham Percutaneous Electrical Nerve StimulationParticipants 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. | Device | Sham PENS |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: Baseline and immediately post-intervention
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.
Thermal Pain Threshold
Time frame: Baseline and immediately post-intervention
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.
1 secondary outcome
Maximal Isometric Wrist Extensor Strength
Time frame: Baseline and immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Serrano Muñoz, Universidad de Castilla-La Man principal investigator
Universidad de Castilla-La Mancha, Faculty of Physiotherapy and Nursing, Toledo, Spain
1 site in 1 country: see every site and its status.
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.