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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)