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 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.