Neuropathic PainNCT07359677
High-frequency Alternating Current Stimulation for Neurophatic Pain in Spinal Cord Injury
A study testing Active group 40 kHz in people with Neuropathic Pain and Spinal Cord Injuries (SCI), run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injuries (SCI)
- What is being tested?
- Active group 40 kHz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2026to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Neuropathic pain affects more than a third of people with spinal cord injuries, reducing their quality of life, and the effectiveness of current treatments is limited. The latest research on healthy volunteers has shown that transcutaneous electrical stimulation with high-frequency blocking currents could have a potential effect on pain, proving to be a safe intervention.
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.
Design: Parallel, randomised, double-blind, placebo-controlled pilot clinical trial.
Participants and location: People with spinal cord injury over the age of 18, with a history of more than three months, neuropathic pain at the level of injury and/or below the level of injury, and pain intensity ≥ 30 mm on the visual analogue scale (VAS) for pain. Participants with any contraindications for the application of transcutaneous electrical stimulation will be excluded. The study will be conducted at the National Hospital for Paraplegics in Toledo.
Intervention: Participants will be randomly assigned to two intervention groups:
Active group (n=15) transcutaneous electrical stimulation with 40kHz alternating currents and Placebo group (n=15) simulated stimulation. The duration of the session in both interventions will be 20 minutes, 10 sessions, over two weeks (5 sessions/week).
Main variables and measurement instruments: The main variable will be the Spanish version of the Neuropathic Pain Symptom Inventory. Secondary variables will be pain perception, which will be assessed using a daily record of spontaneous pain with the VAS scale. The intensity of pain evoked by mechanical stimuli will be assessed using the VAS scale, and pain evoked by thermal stimuli will be assessed using a quantitative sensory test with a Peltier thermode. An ad hoc questionnaire has been designed to assess adverse effects. The assessments will be carried out at four time points: before the intervention, during the intervention, immediately after the intervention, and one week after the intervention.
- Conditions
- Neuropathic Pain, Spinal Cord Injuries (SCI)
- Being tested
- Active group 40 kHz, Sham intervention
- Keywords
- High-frequency alternating current stimulation, Spinal cord injury, Neuropathic pain
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active group 40 kHzDevice
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.
Sham interventionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 40 kHz | Experimental | Alternating current stimulation with a 40kHz frequency with a transcutaneous approach, 20 minutes for each intervention. Receives: Device: Active group 40 kHz |
| Sham stimulation | Sham comparator | Sham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 40kHz group. Receives: Device: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception - NPSI
It will be assessed using the Spanish version of the Neuropathic Pain Symptom Inventory (NPSI), and the result will be taken as the change from baseline at different time points.
This questionnaire has a score ranging from 0 to 100 points, with a higher score indicating greater severity of neuropathic pain symptoms. Regarding the psychometric properties of this questionnaire, it has been shown that the areas under the receiver operating characteristic curves were greater than 0.85 and all reliability coefficients were greater than 0.70.
Measured: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Secondary outcomes (9)
Pain perception - VAS
A daily assessment (Monday to Friday) will be carried out in the morning of self-perceived pain using the visual analogue scale (VAS) (0 mm no pain and 100 mm maximum imaginable pain). The result will be taken as the change from baseline in the weekly mean value of self-perceived pain.
Measured: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Change in pain threshold evoked by mechanical stimuli
The change in pain threshold evoked by mechanical stimuli will be assessed at and below the level of injury-specifically, within the dermatome of the lesion and up to three dermatomes below, and in areas more than three dermatomes below the lesion. Mechanical allodynia will be evaluated using the SenseLab™ Brush-05 (Somedic, Sweden), with two 40 mm brush strokes applied 2 seconds apart. Pinprick pain will be assessed using three stimuli with a 512 mN Von Frey filament no. 12 (OptiHair 2, Germany). In both cases, pain intensity will be rated using a 0-100 mm Visual Analogue Scale (VAS).
Measured: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Change in pain threshold evoked by thermal (cold and heat) stimuli
The change in pain threshold evoked by thermal (cold and heat) stimuli will be assessed at and below the level of injury-specifically, within the dermatome of the lesion and up to three dermatomes below, and in areas more than three dermatomes below the lesion. Thermal pain thresholds will be measured using a 32 × 32 mm Peltier thermode (TSA 2, MEDOC, Israel), with temperature changes from a 30 °C baseline at 1 °C/s. Heat and cold pain thresholds will be recorded using the method of limits, taking the average of three consecutive stimuli. For safety, maximum and minimum cut-offs will be set at 50 °C and 0 °C, respectively.
Measured: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Patient's Overall Impression of Change
A record of the Global Patient Change Rating Scale will be made at post-treatment and during follow-up with respect to the baseline situation. This scale consists of 7 items ranging from '1 = much better' to '7 = much worse'.
Measured: During the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Percentage of participants responding to treatment
The percentage of participants responding to treatment will be evaluated as those who achieve a reduction in pain in the weekly Visual Analog Scale average ≥ 30% and ≥ 50% after treatment and at follow-up.
Measured: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Pain interference with sleep
Pain interference with sleep will be reported in a daily morning log (Monday to Friday) using the VAS scale (0 mm = pain does not interfere with sleep and 100 mm = pain completely interferes with sleep) The result will be taken as the change from baseline in the weekly mean value of pain interference with sleep.
Measured: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Spasticity
To this end, the Modified Ashworth Scale will be used to assess resistance to passive movement in the knee joint bilaterally. The Modified Ashworth Scale ranges from a minimum score of 0 to a maximum score of 4 and is used to assess the degree of muscle spasticity. Higher scores indicate worse outcomes.
Measured: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Frequency of spasms
The Penn Spasm Frequency Scale ranges from a minimum score of 0 to a maximum score of 4 and evaluates the frequency of muscle spasms. Higher scores indicate worse outcomes, reflecting more frequent and severe spasms.
Measured: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Adverse events
Adverse effects related to the electrical current will be recorded using an ad hoc questionnaire specifically designed for this study.
Measured: Week 1 treatment (days 1-5), week 2 treatment (days 6-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start30 Jan 2026
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 40kHz). * Intervention B: sham stimulation (simulated electrical stimulation).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Principal investigator, Castilla La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359677
- Sponsor's protocol ID
- SCI-Neuromodest-gifto
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07359677
- Acronym / sponsor ID
- SCI-Neuromodest-gifto
- Conditions
- Neuropathic Pain, Spinal Cord Injuries (SCI)
- Keywords
- High-frequency alternating current stimulation, Spinal cord injury, Neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuropathic pain affects more than a third of people with spinal cord injuries, reducing their quality of life, and the effectiveness of current treatments is limited. The latest research on healthy volunteers has shown that transcutaneous electrical stimulation with high-frequency blocking currents could have a potential effect on pain, proving to be a safe intervention.
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.
Design: Parallel, randomised, double-blind, placebo-controlled pilot clinical trial.
Participants and location: People with spinal cord injury over the age of 18, with a history of more than three months, neuropathic pain at the level of injury and/or below the level of injury, and pain intensity ≥ 30 mm on the visual analogue scale (VAS) for pain. Participants with any contraindications for the application of transcutaneous electrical stimulation will be excluded. The study will be conducted at the National Hospital for Paraplegics in Toledo.
Intervention: Participants will be randomly assigned to two intervention groups:
Active group (n=15) transcutaneous electrical stimulation with 40kHz alternating currents and Placebo group (n=15) simulated stimulation. The duration of the session in both interventions will be 20 minutes, 10 sessions, over two weeks (5 sessions/week).
Main variables and measurement instruments: The main variable will be the Spanish version of the Neuropathic Pain Symptom Inventory. Secondary variables will be pain perception, which will be assessed using a daily record of spontaneous pain with the VAS scale. The intensity of pain evoked by mechanical stimuli will be assessed using the VAS scale, and pain evoked by thermal stimuli will be assessed using a quantitative sensory test with a Peltier thermode. An ad hoc questionnaire has been designed to assess adverse effects. The assessments will be carried out at four time points: before the intervention, during the intervention, immediately after the intervention, and one week after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 40kHz). * Intervention B: sham stimulation (simulated electrical stimulation).
| Arm | Type | Receives |
|---|---|---|
| Experimental: 40 kHz | Experimental | Device: Active group 40 kHzAlternating current stimulation with a 40kHz frequency with a transcutaneous approach, 20 minutes for each intervention. |
| Sham stimulation | Sham comparator | Device: Sham interventionSham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 40kHz group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active group 40 kHzFor 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. | Device | Experimental: 40 kHz |
| Sham interventionPlacebo 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). | Device | Sham stimulation |
Primary outcome
Pain perception - NPSI
Time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
It will be assessed using the Spanish version of the Neuropathic Pain Symptom Inventory (NPSI), and the result will be taken as the change from baseline at different time points. This questionnaire has a score ranging from 0 to 100 points, with a higher score indicating greater severity of neuropathic pain symptoms. Regarding the psychometric properties of this questionnaire, it has been shown that the areas under the receiver operating characteristic curves were greater than 0.85 and all reliability coefficients were greater than 0.70.
9 secondary outcomes
Pain perception - VAS
Time frame: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Change in pain threshold evoked by mechanical stimuli
Time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Change in pain threshold evoked by thermal (cold and heat) stimuli
Time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Patient's Overall Impression of Change
Time frame: During the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Percentage of participants responding to treatment
Time frame: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Pain interference with sleep
Time frame: Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).
Spasticity
Time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Frequency of spasms
Time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
Adverse events
Time frame: Week 1 treatment (days 1-5), week 2 treatment (days 6-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Avendaño-Coy, PhD principal investigator
Castilla La Mancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active group 40 kHz in people with Neuropathic Pain and Spinal Cord Injuries (SCI), run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception - NPSI (time frame: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.