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Completed

NCT Number: NCT07546318

PENS vs TENS for Hand Function in Multiple Sclerosis

This randomized, parallel, single-blind clinical trial aims to compare the immediate and short-term effects of percutaneous electrical nerve stimulation (PENS) versus transcutaneous electrical nerve stimulation (TENS), applied simultaneously to the median, radial, and ulnar nerves, on hand function in people with multiple sclerosis. Participants will be assessed at baseline, immediately after the intervention, and 72 hours later. Outcomes include fine manual dexterity, gross manual dexterity, pinch strength, and tactile sensitivity.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Burgos

Burgos, 09001, Spain

About this study

Multiple sclerosis frequently affects upper-limb function due to sensorimotor impairments, leading to reduced manual dexterity, impaired coordination, decreased pinch strength, and altered tactile sensitivity. These deficits may limit performance in activities of daily living and reduce functional independence. Peripheral neuromodulation techniques have been increasingly used in neurorehabilitation as complementary interventions to improve sensorimotor function. However, direct comparative evidence between transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS) for hand function in people with multiple sclerosis remains limited.

This study is a randomized, parallel, single-blind clinical trial designed to compare the immediate and short-term effects of TENS and PENS applied simultaneously to the median, radial, and ulnar nerves in individuals with multiple sclerosis. Participants are allocated in a 1:1 ratio to one of two intervention groups. The assessor is blinded to group assignment. Assessments are performed at baseline, immediately after the intervention, and 72 hours after treatment.

The PENS intervention is delivered using sterile 0.25 × 25 mm needles connected to an electrical stimulation device, with low-frequency stimulation (2-4 Hz), sensory intensity with mild motor response, and a treatment duration of 15 minutes. The TENS intervention is applied using surface electrodes placed over the anatomical pathways of the median, radial, and ulnar nerves, with a frequency of 35-50 Hz, pulse duration of 200-350 microseconds, intensity increased gradually until a visible painless muscle contraction is achieved, and a treatment duration of 15 minutes. Both interventions are applied according to standardized anatomical landmarks.

The primary outcome is fine manual dexterity measured with the Nine Hole Peg Test (NHPT). Secondary outcomes include gross manual dexterity measured with the Box and Block Test (BBT), pinch strength measured with a pinch dynamometer, and tactile sensitivity assessed with Semmes-Weinstein monofilaments. The objective is to determine whether PENS provides additional benefit over TENS in improving hand function in people with multiple sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of multiple sclerosis according to McDonald criteria.
  • Age between 18 and 80 years.
  • Clinically stable for at least 2 months before enrollment.
  • No recent corticosteroid treatment.
  • Functional ability to complete the study assessments, defined as a Nine Hole -Peg Test time of less than 300 seconds and the ability to transfer at least 1 block in the Box and Block Test.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

  • Musculoskeletal disorders or injuries affecting the upper limb.
  • Implanted electrical devices.
  • Skin lesions or dermatological conditions at the stimulation sites.
  • Cognitive impairment that interferes with understanding or performing the assessments.
  • Recent relapse or any concomitant neurological condition that could interfere with study participation or evaluation.

Treatment and study plan

Percutaneous Electrical Nerve Stimulation (PENS)

Device

Percutaneous electrical nerve stimulation is delivered with the ITO ES-130 device using sterile 0.25 × 25 mm needles inserted near the median, ulnar, and radial nerves according to anatomical landmarks. Stimulation is applied for 15 minutes at 2-4 Hz, with intensity adjusted to a sensory level with mild visible motor response. The cathode is placed proximally, closest to the nerve, and the anode distally.

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

Participants assigned to this arm receive a single session of transcutaneous electrical nerve stimulation applied simultaneously to the median, ulnar, and radial nerves of the upper limb. Surface electrodes are placed over the anatomical pathways of the target nerves. Stimulation is delivered for 15 minutes with gradual intensity increase until visible painless muscle contraction is achieved. Outcomes are assessed at baseline, immediately after the intervention, and 72 hours later.

Primary outcomes

  1. Fine Manual Dexterity

    Time frame: Baseline, immediately post-intervention, and 72 hours post-intervention.

    Fine manual dexterity will be assessed using the Nine Hole Peg Test (NHPT). The outcome will be the total time, in seconds, required to place and remove the nine pegs as quickly as possible using the most affected hand. Lower values indicate better performance.

Secondary outcomes

  1. Gross Manual Dexterity

    Time frame: Baseline, immediately post-intervention, and 72 hours post-intervention.

    Gross manual dexterity will be assessed using the Box and Block Test (BBT). The outcome will be the number of blocks transferred from one compartment to the other in 60 seconds using the most affected hand. Higher values indicate better performance.

Other outcomes

  1. Lateral Pinch Strength

    Time frame: Baseline, immediately post-intervention, and 72 hours post-intervention.

    Lateral pinch strength will be assessed using a pinch dynamometer. The outcome will be the maximum force generated during lateral pinch between the thumb and the lateral aspect of the index finger in the most affected hand. Higher values indicate greater strength.

  2. Three-Jaw Pinch Strength

    Time frame: Baseline, immediately post-intervention, and 72 hours post-intervention.

    Three-jaw pinch strength will be assessed using a pinch dynamometer. The outcome will be the maximum force generated during pinch involving the thumb, index finger, and middle finger in the most affected hand. Higher values indicate greater strength.

  3. Tactile Sensitivity

    Time frame: Baseline, immediately post-intervention, and 72 hours post-intervention.

    Tactile sensitivity will be assessed using Semmes-Weinstein monofilaments applied to the thumb, index, middle, ring, and little fingers of the most affected hand. The outcome will be the sensory threshold detected with the monofilaments. Lower detection thresholds indicate better tactile sensitivity.

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

Percutaneous Versus Transcutaneous Nerve Stimulation of the Median, Radial, and Ulnar Nerves: Effects on Hand Function in Multiple Sclerosis

Acronym: PENS-TENS-MS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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