Multiple Sclerosis
Conditions
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.
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.
Interventions
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.
DEVICETranscutaneous 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.
Sponsors
Universidad de Burgos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fine Manual Dexterity | 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
| Measure | Time frame | Description |
|---|---|---|
| Gross Manual Dexterity | 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. |
Countries
Spain
Outcome results
None listed