A Study of the Efficacy of Noninvasive Spinal Cord Electrical Stimulation in Neuropathic Pain

Not Applicable

Not yet recruiting

• Conditions: Neuropathic Pain

• Registration Number: NCT07046143
• Lead Sponsor: Nanchang University Affiliated Rehabilitation Hospital

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 trial group (treated with tSCS) and a control group (receiving sham stimulation).The intervention period will be two weeks and the follow-up period will be one year.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 experimental group receiving real and effective non-invasive spinal cord electrical stimulation (Device A), while the control group received sham stimulation (Device B), which was identical in appearance, interface parameters, and stimulation sensation, but did not have any actual therapeutic effect.Throughout the double-blind intervention, neither the subjects nor the researchers 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 was placed on the patient's bilateral anterior superior iliac spines, and the cathode was placed on the spines at the spines of the nerve root outlets corresponding to the upper and lower spinal segments.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 researchers adjusted the amplitude of the current, and gradually increased the amplitude to the sensory threshold, and then decreased the amplitude of the current to below the sensory threshold until the patients could not feel the sensory abnormality regardless of their body position.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 and control groups received noninvasive spinal electrical stimulation for 20 min each time, twice a day for 2 weeks.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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-05-31
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-07-15
• Primary Completion: 2026-06-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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, with VAS ≥5 points;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment	assesses the quality of a patient's sleep
Self-assessment scale for depression	Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment	Depression scale: mild depression (53-62 points); severe depression (63-72 points); severe depression (\>72 points).
Patient General Impression of Improvement Scale	Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment	to assess patient self-perceived improvement in pain
Quality of Life Scale	Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment	for assessing the overall quality of life of patients
Self-assessment scale for anxiety	Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment	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).

Trial Locations

Locations (1)

NanChang; 🇨🇳 Nanchang, Jiangxi, China