Neuropathic PainNCT07046143
Study on the Efficacy of Non-invasive Spinal Cord Electrical Stimulation in Neuropathic Pain
A study testing tSCS in people with Neuropathic Pain, run by Nanchang University Affiliated Rehabilitation Hospital at 1 site in China.
Trial summary
This study is a randomized, double-blind, controlled clinical trial designed to evaluate the impact of non-invasive spinal cord electrical stimulation (tSCS) on the outcome of patients with neuropathic pain.Subjects will be randomized into a test group (treated with tSCS) and a control group (receiving sham… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- tSCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old;
- Meet the diagnostic criteria for neuropathic pain
- Chronic low back pain due to neuropathic pain, with or without leg pain;
- The skin at the site of irritation is intact;
- The patient's vital signs are stable.
Who cannot join
- Pain is mainly caused by non-neuropathic factors, such as acute inflammation and trauma;
- Those with severe mental illness affecting the study assessment, those with severe cognitive impairment unable to communicate normally or with very poor compliance;
- Accompanied by severe cardiac, hepatic, renal and other vital organ insufficiency;
- Recently received other related treatments that may affect the impact of neuropathic pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of the Efficacy of Noninvasive Spinal Cord Electrical Stimulation in Neuropathic Pain
This study is a randomized, double-blind, controlled clinical trial designed to evaluate the impact of non-invasive spinal cord electrical stimulation (tSCS) on the outcome of patients with neuropathic pain.Subjects will be randomized into a test group (treated with tSCS) and a control group (receiving sham stimulation).The intervention period was during the patient's hospitalization, with a follow-up period of 3 months.Patients' pain and quality of life will be assessed at baseline, at the end of the intervention, and during the follow-up period to compare the difference in efficacy between the two groups.
Read the detailed description
The study subjects were patients with low back pain caused by neuropathic pain patients, who were assessed and screened by professionally trained medical personnel according to the inclusion and exclusion criteria, and those who met the enrollment criteria signed an informed consent form after they gave their informed consent and were formally included in the study. A computerized randomization system was applied to randomly divide them into a test group and a control group.Both groups were operated with non-invasive spinal cord stimulation devices manufactured by the same company, with the test group receiving real and effective non-invasive spinal cord electrical stimulation (Device A), while the control group received placebo stimulation (Device B). Throughout the double-blind intervention, neither the subjects nor the assesseors who operated the devices were aware of the difference between the two devices (Device A and Device B) and were completely blinded.
For the subjects randomized to receive noninvasive spinal cord electrical stimulation, the unblinded researchers carried out the study according to the following research steps: ① Before the treatment, the patient's skin was wiped with 75% alcohol, and the patient was asked to take a prone or sitting position, The anode is placed above the anterior superior iliac spine on the affected side, while the cathode covers the paravertebral region of the lumbosacral enlargement corresponding to the painful dermatome.② The stimulation frequency was adjusted to 10,000Hz, the treatment frequency was 30Hz, the pulse width was 1ms, the waveform was square wave, and the duration of single treatment was 20min. ③ The test group's stimulation intensity was set at the patient's tolerable threshold. The placebo control group's initial stimulation intensity was set at the sensory threshold, maintained for 30 seconds, and then gradually reduced to zero over the remaining duration.④ The equipment was sterilized by wiping with 75% alcohol after the treatment.Subjects randomized to receive sham stimulation operated according to the above study steps, and the device output interface adjustment parameters were all consistent. Both the test group and the control group received non-invasive spinal cord electrical stimulation during hospitalization, twice daily for 20 minutes each session. During the study period, subjects in both groups received the same other conventional rehabilitation treatments.
The basic information of the patients was recorded before treatment, including gender, age, etiology, and duration of the disease.The McGill Pain Questionnaire (MPQ), Visual Analog Scale (VAS), Oswestry Dysfunction Index Questionnaire (ODI), EEG data during tSCS stimulation, Quality of Life Scale (SF-36), and Patient General ImpressionImprovement Scale (CGI-1), Pittsburgh Sleep Quality Index (PSQI), Self-Assessment Scale for Anxiety (SAS), Self-Assessment Scale for Depression (SDS).
- Conditions
- Neuropathic Pain
- Being tested
- tSCS
- Keywords
- Transcutaneous spinal cord electrical stimulation, Neuropathic Pain, lumbago
- Medical subject headings
- Neuralgia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tSCSDevice
The test group received non-invasive spinal cord electrical stimulation therapy during hospitalization. Patients were positioned prone or seated, with the anode placed above the iliac crest on the affected side and the cathode covering the paravertebral region of the lumbosacral enlargement corresponding to the painful dermatome. The stimulation frequency was adjusted to 10,000 Hz, with a treatment frequency of 30 Hz and a pulse width of 1 millisecond. The waveform was square, with each treatment session lasting 20 minutes. Stimulation intensity was set to the patient's tolerable threshold. Sessions were administered twice daily, each lasting 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | The experimental group received noninvasive spinal cord electrical stimulation treatment Receives: Device: tSCS |
| control group | No intervention | The placebo control group's initial stimulation intensity was set at the sensory threshold, maintained for 30 seconds, and then gradually reduced to zero over the remaining duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire
McGill Pain Questionnaire (MPQ): (1) The questionnaire contains two main categories, the Pain Rating Index (PRI) and the Pain Intensity (PI). (2) The PRI section consists of 20 subcategories totaling 78 descriptive words, and patients are asked to mark one word from each category that best indicates their pain (no suitable may be left unchecked), and these words indicate the different components of pain. categories 1-10 are sensory, 11-15 are affective, 16 are evaluative, and 17-20 are other.Scores are 0-78, with 0 being no pain and 78 being severe pain. (3) The PPI can be used to assess the intensity of generalized pain on a scale of 0-5, with the higher the score, the more pronounced the pain.
Measured: Study pre-intervention and post-intervention weeks one and two
The Oswestry Dysfunction Index Questionnaire
The Oswestry Dability Index is a 10-question questionnaire consisting of 10 questions on pain intensity, self-care, lifting, walking, sitting, standing, disturbed sleep, sexuality, social life, and travel, with 6 options for each question and a maximum score of 5 for each question.The maximum score for each question is 5 points, 0 points for the first option and 5 points for the last option in that order. If all 10 questions are answered, the score is: actual score/50 (highest possible score) x 100%, and if one question is not answered, the score is: actual score/45 (highest possible score) x 100%, with higher scores indicating more severe dysfunction.
Measured: Study pre-intervention and post-intervention weeks one and two
Visual Analog Scale
Visual analog scoring method.A 10 cm horizontal line was drawn on the paper, with 0 mm at one end of the line, indicating "no pain at all", and 10 mm at the other end, indicating "extreme pain"; the pain level increased from 0 mm to 10 mm, and the higher the score, the more intense the pain.The higher the score, the more intense the pain.
Measured: Study pre-intervention and post-intervention weeks one and two
EEG
The recording parameters are as follows: recording bandwidth(dc-1000hz)，sampling rate (1000hz). The main measures of eeg are as follows and focued on 0.1- 40hz thus include delta, theta, alpha, beta and gamma band: qualitative waveform, power spectral density, fuctional connectivity, graph theory measurs. However, since biomarkers of pain is just one of the study objectives, we can not determine all measures that might be used in the future.
Measured: Study pre-intervention and post-intervention weeks one and two
Secondary outcomes (5)
Quality of Life Scale
for assessing the overall quality of life of patients
Measured: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Patient General Impression of Improvement Scale
to assess patient self-perceived improvement in pain
Measured: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Pittsburgh Sleep Quality Index
assesses the quality of a patient's sleep
Measured: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Self-assessment scale for anxiety
assessment of the patient's psychological status. Anxiety scale: normal (<50 points); mild anxiety (50-60 points); moderate anxiety (61-70 points); severe anxiety (>70 points).
Measured: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Self-assessment scale for depression
Depression scale: mild depression (53-62 points); severe depression (63-72 points); severe depression (>72 points).
Measured: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start25 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchang University Affiliated Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Zeng, Nanchang University Affiliated Rehabilitation Hospital
- Investigators
- Ying Liang, Study director, Affiliated Rehabilitation Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046143
- Sponsor's protocol ID
- SFYLL-KY-PJ-2025-003
- Status last verified
- Sep 2025
- First submitted
- 31 May 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Noninvasive Spinal Cord Electrical Stimulation in Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07046143
- Acronym / sponsor ID
- SFYLL-KY-PJ-2025-003
- Conditions
- Neuropathic Pain
- Keywords
- Transcutaneous spinal cord electrical stimulation, Neuropathic Pain, lumbago
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Nanchang University Affiliated Rehabilitation HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
This study is a randomized, double-blind, controlled clinical trial designed to evaluate the impact of non-invasive spinal cord electrical stimulation (tSCS) on the outcome of patients with neuropathic pain.Subjects will be randomized into a test group (treated with tSCS) and a control group (receiving sham stimulation).The intervention period was during the patient's hospitalization, with a follow-up period of 3 months.Patients' pain and quality of life will be assessed at baseline, at the end of the intervention, and during the follow-up period to compare the difference in efficacy between the two groups.
Detailed description
The study subjects were patients with low back pain caused by neuropathic pain patients, who were assessed and screened by professionally trained medical personnel according to the inclusion and exclusion criteria, and those who met the enrollment criteria signed an informed consent form after they gave their informed consent and were formally included in the study. A computerized randomization system was applied to randomly divide them into a test group and a control group.Both groups were operated with non-invasive spinal cord stimulation devices manufactured by the same company, with the test group receiving real and effective non-invasive spinal cord electrical stimulation (Device A), while the control group received placebo stimulation (Device B). Throughout the double-blind intervention, neither the subjects nor the assesseors who operated the devices were aware of the difference between the two devices (Device A and Device B) and were completely blinded.
For the subjects randomized to receive noninvasive spinal cord electrical stimulation, the unblinded researchers carried out the study according to the following research steps: ① Before the treatment, the patient's skin was wiped with 75% alcohol, and the patient was asked to take a prone or sitting position, The anode is placed above the anterior superior iliac spine on the affected side, while the cathode covers the paravertebral region of the lumbosacral enlargement corresponding to the painful dermatome.② The stimulation frequency was adjusted to 10,000Hz, the treatment frequency was 30Hz, the pulse width was 1ms, the waveform was square wave, and the duration of single treatment was 20min. ③ The test group's stimulation intensity was set at the patient's tolerable threshold. The placebo control group's initial stimulation intensity was set at the sensory threshold, maintained for 30 seconds, and then gradually reduced to zero over the remaining duration.④ The equipment was sterilized by wiping with 75% alcohol after the treatment.Subjects randomized to receive sham stimulation operated according to the above study steps, and the device output interface adjustment parameters were all consistent. Both the test group and the control group received non-invasive spinal cord electrical stimulation during hospitalization, twice daily for 20 minutes each session. During the study period, subjects in both groups received the same other conventional rehabilitation treatments.
The basic information of the patients was recorded before treatment, including gender, age, etiology, and duration of the disease.The McGill Pain Questionnaire (MPQ), Visual Analog Scale (VAS), Oswestry Dysfunction Index Questionnaire (ODI), EEG data during tSCS stimulation, Quality of Life Scale (SF-36), and Patient General ImpressionImprovement Scale (CGI-1), Pittsburgh Sleep Quality Index (PSQI), Self-Assessment Scale for Anxiety (SAS), Self-Assessment Scale for Depression (SDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: tSCSThe experimental group received noninvasive spinal cord electrical stimulation treatment |
| control group | No intervention | –The placebo control group's initial stimulation intensity was set at the sensory threshold, maintained for 30 seconds, and then gradually reduced to zero over the remaining duration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old;
- Meet the diagnostic criteria for neuropathic pain
- Chronic low back pain due to neuropathic pain, with or without leg pain;
- The skin at the site of irritation is intact;
- The patient's vital signs are stable.
Key exclusion criteria (4 listed)
- Pain is mainly caused by non-neuropathic factors, such as acute inflammation and trauma;
- Those with severe mental illness affecting the study assessment, those with severe cognitive impairment unable to communicate normally or with very poor compliance;
- Accompanied by severe cardiac, hepatic, renal and other vital organ insufficiency;
- Recently received other related treatments that may affect the impact of neuropathic pain.
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 |
|---|---|---|
| tSCSThe test group received non-invasive spinal cord electrical stimulation therapy during hospitalization. Patients were positioned prone or seated, with the anode placed above the iliac crest on the affected side and the cathode covering the paravertebral region of the lumbosacral enlargement corresponding to the painful dermatome. The stimulation frequency was adjusted to 10,000 Hz, with a treatment frequency of 30 Hz and a pulse width of 1 millisecond. The waveform was square, with each treatment session lasting 20 minutes. Stimulation intensity was set to the patient's tolerable threshold. Sessions were administered twice daily, each lasting 20 minutes. | Device | test group |
Primary outcome
McGill Pain Questionnaire
Time frame: Study pre-intervention and post-intervention weeks one and two
McGill Pain Questionnaire (MPQ): (1) The questionnaire contains two main categories, the Pain Rating Index (PRI) and the Pain Intensity (PI). (2) The PRI section consists of 20 subcategories totaling 78 descriptive words, and patients are asked to mark one word from each category that best indicates their pain (no suitable may be left unchecked), and these words indicate the different components of pain. categories 1-10 are sensory, 11-15 are affective, 16 are evaluative, and 17-20 are other.Scores are 0-78, with 0 being no pain and 78 being severe pain. (3) The PPI can be used to assess the intensity of generalized pain on a scale of 0-5, with the higher the score, the more pronounced the pain.
The Oswestry Dysfunction Index Questionnaire
Time frame: Study pre-intervention and post-intervention weeks one and two
The Oswestry Dability Index is a 10-question questionnaire consisting of 10 questions on pain intensity, self-care, lifting, walking, sitting, standing, disturbed sleep, sexuality, social life, and travel, with 6 options for each question and a maximum score of 5 for each question.The maximum score for each question is 5 points, 0 points for the first option and 5 points for the last option in that order. If all 10 questions are answered, the score is: actual score/50 (highest possible score) x 100%, and if one question is not answered, the score is: actual score/45 (highest possible score) x 100%, with higher scores indicating more severe dysfunction.
Visual Analog Scale
Time frame: Study pre-intervention and post-intervention weeks one and two
Visual analog scoring method.A 10 cm horizontal line was drawn on the paper, with 0 mm at one end of the line, indicating "no pain at all", and 10 mm at the other end, indicating "extreme pain"; the pain level increased from 0 mm to 10 mm, and the higher the score, the more intense the pain.The higher the score, the more intense the pain.
EEG
Time frame: Study pre-intervention and post-intervention weeks one and two
The recording parameters are as follows: recording bandwidth(dc-1000hz)，sampling rate (1000hz). The main measures of eeg are as follows and focued on 0.1- 40hz thus include delta, theta, alpha, beta and gamma band: qualitative waveform, power spectral density, fuctional connectivity, graph theory measurs. However, since biomarkers of pain is just one of the study objectives, we can not determine all measures that might be used in the future.
5 secondary outcomes
Quality of Life Scale
Time frame: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Patient General Impression of Improvement Scale
Time frame: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Pittsburgh Sleep Quality Index
Time frame: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Self-assessment scale for anxiety
Time frame: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Self-assessment scale for depression
Time frame: Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
Ying Liang study director
Affiliated Rehabilitation Hospital of Nanchang 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 tSCS in people with Neuropathic Pain, run by Nanchang University Affiliated Rehabilitation Hospital at 1 site in China.
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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
McGill Pain Questionnaire (time frame: Study pre-intervention and post-intervention weeks one and two). The study lists 4 primary outcomes in all. 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 22 Dec 2025.