Selective nociceptive modulation using a novel prototype of transcutaneous kilohertz high-frequency alternating current stimulation: a crossover double-blind randomized sham-controlled trial.
Juan José Fernández-Pérez, Diego Serrano-Muñoz, Julio Gómez-Soriano and 2 others
PMID 39548560WHAT IT FOUND
40 kHz transcutaneous kilohertz stimulation raised pressure pain thresholds in healthy volunteers more than sham, with no effect on touch or strength.
It was well tolerated. This is a physiological finding in pain-free people, not evidence it treats pain.
Key findings
0140 kHz stimulation increased pressure pain threshold by 9.8 N/cm2 during intervention compared to sham, a change exceeding the minimal clinically important difference of 10 N/cm2 in healthy subjects.
02No significant differences were found between active stimulation and sham for secondary outcomes including two-point discrimination, pinch strength, or sensory nerve action potential amplitude.
03Participants were not successfully blinded to active stimulation, recognizing they received treatment, although assessors were generally blinded.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The study was conducted on healthy volunteers, so the effects cannot be assumed to apply to people with chronic pain or neurological conditions. Participants were not successfully blinded to the active stimulation, which may have influenced subjective pain threshold reporting. The device used was a prototype not approved for clinical use, and the maximum intensity at 50 kHz was limited by the device's output, potentially underdosing that frequency. The effects on heat pain threshold did not reach the minimal clinically important difference, even when statistically significant. The study used indirect measures (pain thresholds) to infer nerve fiber blockade, rather than direct neural recordings.
Declared interests
The study was supported by non-U.S. government funding. The prototype device was developed by the research group's institution (Cibertec S.A.), which may have a commercial interest in the technology, though specific financial disclosures are not detailed in the text provided.
The easy way to misread this
Do not interpret the increased pain thresholds in healthy volunteers as evidence that this stimulation treats pain in patients. The participants knew when they received active treatment, which can bias pain reporting, and the device is not approved for clinical use.