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

Sponsor
Nanchang University Affiliated Rehabilitation Hospital
Study ID
NCT07046143
Status
Enrolling By Invitation

Conditions

  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 1, 2025
Start date
Jun 25, 2025
Status verified
Sep 2025
Primary completion
Jun 15, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: test group
    The experimental group received noninvasive spinal cord electrical stimulation treatment
  • No Intervention: 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.

Primary Outcome Measure

McGill Pain Questionnaire [ Time Frame: Study pre-intervention and post-intervention weeks one and two ]

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