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

NCT07046143 | Enrolling By Invitation

• 1 other identifier: SFYLL-KY-PJ-2025-003
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Transcutaneous spinal cord electrical stimulation; Neuropathic Pain; lumbago

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Study pre-intervention and post-intervention weeks one and two

Secondary Outcomes (5)

• Quality of Life Scale

  Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment

• Patient General Impression of Improvement Scale

  Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment

• Pittsburgh Sleep Quality Index

  Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment

• Self-assessment scale for anxiety

  Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment

• Self-assessment scale for depression

  Pre-treatment and first week, second week, 3 months, 6 months, 1 year post-treatment

Study Arms (2)

test group

EXPERIMENTAL

The experimental group received noninvasive spinal cord electrical stimulation treatment

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.

Interventions

tSCS 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.

test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanchang University Affiliated Rehabilitation Hospital: lead

Study Sites (1)

NanChang

Nanchang, Jiangxi, 330003, China

Location

MeSH Terms

Conditions

Neuralgia; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Ying Liang

  Affiliated Rehabilitation Hospital of Nanchang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: July 1, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-09

Locations

CN (1)