PENS vs TENS for Hand Function in Multiple Sclerosis (PENS-TENS-MS)

Percutaneous Versus Transcutaneous Nerve Stimulation of the Median, Radial, and Ulnar Nerves: Effects on 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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Percutaneous Electrical Nerve Stimulation (PENS); Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos
    • Burgos, Burgos, Spain, 09001
      • University of Burgos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Electrical Nerve Stimulation (PENS); Participants assigned to this arm receive a single session of percutaneous electrical nerve stimulation applied simultaneously to the median, ulnar, and radial nerves of the upper limb. Stimulation is delivered using sterile 0.25 × 25 mm needles connected to an electrical stimulation device. Treatment is applied for 15 minutes using low-frequency stimulation (2-4 Hz) at sensory intensity with a mild motor response. Outcomes are assessed at baseline, immediately after the intervention, and 72 hours later.	Device: Percutaneous Electrical Nerve Stimulation (PENS); 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.
Active Comparator: Transcutaneous Electrical Nerve Stimulation (TENS); 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	Device: Transcutaneous Electrical Nerve Stimulation (TENS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fine Manual Dexterity	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.	Baseline, immediately post-intervention, and 72 hours post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Manual Dexterity	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.	Baseline, immediately post-intervention, and 72 hours post-intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lateral Pinch Strength	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.	Baseline, immediately post-intervention, and 72 hours post-intervention.
Three-Jaw Pinch Strength	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.	Baseline, immediately post-intervention, and 72 hours post-intervention.
Tactile Sensitivity	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.	Baseline, immediately post-intervention, and 72 hours post-intervention.

Collaborators and Investigators

• Sponsor: Universidad de Burgos

Publications and helpful links

General Publications

• Javier-Ormazabal A, Herrero P, Gonzalez-Platas M. Ultrasound-Guided Percutaneous Neuromodulation in Multiple Sclerosis: A Case Report. Degener Neurol Neuromuscul Dis. 2023 Jan 27;13:15-20. doi: 10.2147/DNND.S395082. eCollection 2023.
• Kraft GH, Amtmann D, Bennett SE, Finlayson M, Sutliff MH, Tullman M, Sidovar M, Rabinowicz AL. Assessment of upper extremity function in multiple sclerosis: review and opinion. Postgrad Med. 2014 Sep;126(5):102-8. doi: 10.3810/pgm.2014.09.2803.
• Bertoni R, Cattaneo D, Grosso C, Baglio F, Jonsdottir J. Distribution and relation of two arm function tests, Box and Blocks test and Nine Hole Peg test, across disease severity levels and types of multiple sclerosis. Mult Scler Relat Disord. 2022 Mar;59:103683. doi: 10.1016/j.msard.2022.103683. Epub 2022 Feb 9.
• Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): March 15, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: UBU-EM-PENS-TENS-2026; IO 01/2026 (Other Identifier: Universidad de Burgos)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a small single-center study, and no formal data-sharing plan was established in the study protocol. Only de-identified aggregate results will be reported

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No