Noninvasive Peripheral Nerve Stimulation Device May Be Effective Option for Treating Pain

A new study published in Pain and Therapy confirms results of smaller prior studies demonstrating potential benefits of a noninvasive peripheral nerve stimulation device (BioWaveHOME; BioWave, Norwalk, CT) for treating chronic pain. The BioWaveHOME device consists of a stimulator device, lead wire cable, various electrodes to be used on different body parts, and an electrical charger. According to details provided by the company on their website, the BioWaveHome device delivers high-frequency neurostimulation through the skin directly to pain nerves, “inhibiting action potential propagation along the nerve and blocking transmission of pain signals to the brain.”

The 5 main, self-reported outcomes of the pilot study of 1511 participants after they used the device for 2 weeks were:

• Forty-six percent (46%) reduction in median pain scores
• An average reduction in pain scores of 3.47 points (P<.001)
• Improvements in quality of life reported in 87.6% of participants, including improvements in sleep and mood
• Forty-two percent (42%) of patients reported that they were able to eliminate or reduce their pain medication.
• More than 97% of patients wanted to continue using the device.
• No serious adverse reactions or complications were reported.

This open-label pilot study enlisted individuals with chronic pain from various sites, including through the Veterans Affairs, orthopedic hospitals, and pain centers. The most common chronic pain locations cited by participants included back pain (60%), neck pain (9%), and ankle/foot pain (8%). Participants in the study received detailed instructions in the use of the device; additional details about the frequency and intensity of treatments as well as electrode placement may be found in the manufacturer’s website: https://biowave.com/wp-content/uploads/2021/09/BWH-Users-Manual-US-v14-210409.pdf. Participants were mailed the device and received a questionnaire consisting of questions related to pain and quality of life measures to complete and return.  

The authors note the many limitations of the study, stating “Although survey studies have inherent limitations such as duration and compliance biases, with such an overwhelming benefit in every category we believe that non-invasive neuromodulation therapy is a promising, safe, and cost-effective therapy. Future studies should focus on long-term follow-ups and post-therapy pain scores with a placebo group.”