OBJECTIVE: To evaluate the effectiveness and safety of noninvasive kilohertz frequency alternating current (KHFAC) therapy for neuropathic pain in patients following spinal cord injury.
METHODS: In this randomized, single-blind, sham-controlled trial conducted from June 1, 2023, to January 31, 2024, 50 patients suffering from neuropathic pain post-spinal cord injury were assigned to receive either KHFAC or sham stimulation for 7 days, complemented by twice-daily oral administration of 75 mg pregabalin. Outcomes were assessed using the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Brief Pain Inventory (BPI) at baseline, at the end of treatment, and 30 days post-treatment. The primary outcome was the effective rate at the end of treatment, defined as a decrease in VAS score of 30% or more.
RESULTS: At the end of the 7-day treatment period, the experimental group demonstrated a significantly higher response rate, with 60% of participants achieving a 30% or greater reduction in VAS scores compared to 28% in the control group (X²=5.195, P<0.05). During this initial period, KHFAC effectively decreased pain intensity, reduced the frequency of paroxysmal pain, and lessened the need for additional analgesics. It also improved sleep quality and overall quality of life relative to sham stimulation. However, at the 30-day follow-up, no statistically significant differences were observed between the groups.
CONCLUSION: KHFAC is effective and safe for short-term neuropathic pain relief and quality of life enhancement in spinal cord injury patients, without an increase in adverse events versus sham stimulation. However, while reductions in analgesic use suggest potential lasting benefits, the long-term effectiveness remains uncertain. Further studies are required to assess the persistence of these effects.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2300068114.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
No significant difference between the treatment and placebo group at one-month follow-up as could be expected according to previous studies.
Physician rater
KHFAC is an efficacious, noninvasive, and safe short-term option for neuropathic pain in patients with SCI who are already undergoing pharmacological treatment. However, the trial's limited duration and small patient cohort prevent drawing conclusions about long-term efficacy and generalizability. Additional research is needed to determine whether prolonged or repeated use provides persistent pain relief. The cost-benefit ratio of the KHFAC treatment was not considered.
Physician rater
This trial shows that noninvasive KHFAC, when added to standard drug therapy, offers short-term improvements in pain and quality of life for SCI-related neuropathic pain, with a strong safety profile, but its benefits wane over time, as by one month the differences between groups were no longer statistically significant in pain relief, sleep quality, or analgesic use, suggesting the effect is short-term and highlighting the need for more research on these neuromodulation approaches.
, McMaster University