PENS vs TENS for Hand Function in Multiple Sclerosis

NCT07546318 | Completed

• 2 other identifiers: UBU-EM-PENS-TENS-2026IO 01/2026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gross Manual Dexterity

  Baseline, immediately post-intervention, and 72 hours post-intervention.

Other Outcomes (3)

• Lateral Pinch Strength

  Baseline, immediately post-intervention, and 72 hours post-intervention.

• Three-Jaw Pinch Strength

  Baseline, immediately post-intervention, and 72 hours post-intervention.

• Tactile Sensitivity

  Baseline, immediately post-intervention, and 72 hours post-intervention.

Study Arms (2)

Percutaneous Electrical Nerve Stimulation (PENS)

EXPERIMENTAL

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)

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

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)

Interventions

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.

Percutaneous Electrical Nerve Stimulation (PENS)

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.

Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

University of Burgos

Burgos, Burgos, 09001, Spain

Location

Related Publications (4)

• 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.

  PMID: 36733290 RESULT

• 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.

  PMID: 25295653 RESULT

• 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.

  PMID: 35168094 RESULT

• 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.

  PMID: 28206826 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses a single-blind design in which the outcome assessor is blinded to group assignment. Participants are informed about the general study procedures but do not know which intervention they will receive until the time of application. Different physiotherapists deliver each intervention, and the evaluator remains unaware of the assigned treatment group throughout the assessment process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned in a 1:1 ratio to 1 of 2 parallel intervention groups: percutaneous electrical nerve stimulation (PENS) or transcutaneous electrical nerve stimulation (TENS). Both interventions are applied in a single session to the median, radial, and ulnar nerves. Outcomes are assessed at baseline, immediately after the intervention, and 72 hours after treatment.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: January 1, 2026
• Primary Completion: March 15, 2026
• Study Completion: April 14, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)