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| ID | Type | Description | Link |
|---|---|---|---|
| IO 01/2026 | Other Identifier | Universidad de Burgos |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Burgos | Burgos | Burgos | 09001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36733290 | Result | 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. | |
| 25295653 | 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. |
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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
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
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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.
|
| 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. |
|
| 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. |
| 35168094 | 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. |
| 28206826 | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |