Study on the Efficacy of Non-invasive Spinal Cord Electrical Stimulation in Neuropathic Pain

NCT ID: NCT07046143

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2026-07-15

Brief 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 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).

Conditions

Neuropathic Pain

Keywords

Transcutaneous spinal cord electrical stimulation; Neuropathic Pain; lumbago

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

test group

The experimental group received noninvasive spinal cord electrical stimulation treatment

Group Type: EXPERIMENTAL

tSCS

Intervention Type: DEVICE

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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tSCS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanchang University Affiliated Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wentao Zeng

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Liang

Role: STUDY_DIRECTOR

Affiliated Rehabilitation Hospital of Nanchang University

Locations

NanChang

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

SFYLL-KY-PJ-2025-003

Identifier Type: -

Identifier Source: org_study_id