An Open-Label Pilot Study Investigating Noninvasive High-Frequency Peripheral Nerve Fiber Stimulation in Chronic Pain.

Objective: Providing sustained and effective treatment via the peripheral nervous system for the management of chronic pain is challenging. Application of noninvasive high-frequency stimulation at or near the painful area may benefit those with chronic pain. This open-label pilot survey examined the impact of this stimulation on pain intensity, activities of daily living, functional capacity, and medication consumption after 2 weeks of treatment.

Methods: Stimulation was administered at home using the summation of two high-frequency sinusoidal alternating signals at 3858 and 3980 Hz delivered between two electrodes placed directly over one or two locations of pain. Individuals completed a survey after 2 weeks to assess pain, activities of daily living (ADL), pain medication consumption, quality of life (QoL), mood, sleep, functional outcomes, and satisfaction.

Results: 463 individuals (372 males; 91 females) retuned the completed survey after 2 weeks of treatment. Pain and ADL scores significantly improved at follow-up compared with baseline (pain mean difference: 3.05; 95% confidence interval [CI]: 2.86, 3.24; ADL mean difference: 1.82; 95% CI: 1.60, 2.04). Corresponding improvements in QoL, sleep, mood, functional outcomes, and satisfaction were noted. On average, 8.00 ± 11.11 hours of pain relief were reported with 54% experiencing reductions in pain medication consumption. 98% would use the stimulation in the future.

Conclusion: Two weeks of noninvasive high-frequency peripheral nerve fiber stimulation appeared to confer positive effects in individuals with chronic pain. Future research employing a control group/arm is needed to establish the long-term impact of this bioelectric technique in specific pain cohorts.