High-frequency Alternating Current Stimulation for Neurophatic Pain in Spinal Cord Injury
Effectiveness and Safety of Transcutaneous Electrical Stimulation With 40 kHz Alternating Currents in People With Spinal Cord Injury and Neuropathic Pain. A Randomised, Double-blind, Parallel Pilot Study With Placebo Control
University of Castilla-La Mancha
30 participants
Jan 30, 2026
INTERVENTIONAL
Conditions
Summary
To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.
Eligibility
Inclusion Criteria9
- People with spinal cord injuries of any aetiology affecting the D1 spinal cord level or lower (paraplegia)
- With injury grade A, B, C, or D according to the ASIA (American Spinal Injury Association) Impairment Scale (AIS)
- Time since spinal cord injury ≥ 3 months
- A score of ≥ 4 points on the Dolour Neuropathique 4 (DN4) scale
- Neuropathic pain at the level of the injury (within the dermatome at that level and up to three dermatomes below) and/or below the level of the injury (more than three dermatomes below)
- Duration of pain ≥ 1 month
- Average pain perception score ≥ 30 mm on the visual analogue scale (VAS) in the week prior to eligibility, with a daily record of 5 days (Monday to Friday) in the morning.
- Be able to understand instructions and assessment tools
- Agree to participate in the study and sign the informed consent form
Exclusion Criteria9
- Cauda equina injuries
- Brain injuries or other central nervous system injuries concomitant with spinal cord injury
- A value of 100 mm in any of the daily records collected in the week prior to eligibility
- Having any contraindications for the application of transcutaneous electrical stimulation: cardiac pacemaker or any other implanted electrical device, epilepsy, pregnancy, active malignant tumours in the area of application of the stimulation, and wounds or skin damage in the area of stimulation
- History of psychiatric illness
- Major depression
- Spinal cord injury caused by autolysis
- Changes in medication prescribed for the treatment of pain and spasticity during the study
- Acute nociceptive pain in any area of the body during the study
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Interventions
For experimental electrical stimulation, two stainless steel electrodes with conductive gel will be applied over the bilateral spinal roots with a separation between electrodes of at least 2 cm and a distance between the medial edge of each electrode and the spinous process of at least 1 cm. The upper third of the electrode will be placed above the level of spinal cord injury where the participant will have preserved sensitivity, and the remaining two thirds in the lesion and/or infralesional area. An unmodulated rectangular alternating or biphasic electrical current with a frequency of 40 kHz will be applied. The intensity of the current will be adjusted individually, increasing it until the participant reports a sensation of 'strong but comfortable tingling' just below the motor threshold. Every two minutes, the intensity of the current will be adjusted if the tingling sensation decreases. The electrical current will be applied for 20 minutes in two 10-minute phases.
Placebo stimulation will be performed using the same electrical current device, the same electrode placement, and the same stimulation parameters as in the experimental stimulation, but the current intensity will be increased only during the initial 30 initial seconds and the final 30 seconds of the session, with the current intensity set to 0 mA for the rest of the intervention (20 minutes).
Locations(1)
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NCT07359677