RCT Study Tests Efficacy of Wearable Nerve Stim

A new peer-reviewed randomized controlled clinical study titled “High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study” published in the Journal of Pain Research has shown “encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT [high-frequency impulse therapy].”

The study enrolled 36 patients with chronic low back pain from 5 California-based orthopedic and pain center sites. The study compared patient outcomes when treated with high-frequency impulse therapy device to patient outcomes when treated by a control sham device.

A group of University of California San Francisco and Memorial Sloan Kettering Cancer Center researchers designed and conducted the study, led by Kasra Amirdelfan, of IPM Medical Group of Walnut Creek, California.

The research team collected patient pain and function data using the Six Minute Walk Test (6MWT), Timed Up and Go (TUG), Oswestry Disability Index (ODI)),  the Numerical Rating Scale (NRS) for pain and the Patient Global Impression of Change (PGIC) for quality of life and device use.

The team collected data at baseline and then followed-up every week for 4 weeks. They used the Mann–Whitney U-test to analyze changes in each outcome and then repeated measures ANOVA [analysis of variance] to assess the effect of treatment over time.

Participants in the study who received high-frequency impulse therapy had a significantly higher Six Minute Walk Test scores at weeks two and four, significantly lower Timed Up and Go scores at week three, and significantly lower Numerical Rating Scale scores at weeks two and four.

The researchers concluded that “A larger-scale randomly controlled study can build on the findings of this study in order to test whether high-frequency impulse therapy is effective in reducing pain and improving function in chronic low back pain patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used high-frequency impulse therapy. The efficacy and minimally invasive nature of high-frequency impulse therapy is anticipated to substantially improve the management of chronic low back pain patients.”

San Francisco, California-based Hinge Health Inc., a Digital MSK (musculoskeletal) Clinic™, was the sponsor of the study, which used Enso, its wearable technology for electrical nerve stimulation.

OTW spoke with Hinge Health Medical Director Louis Dickey, M.D. about the Enso device. Dr. Dickey told us, “A wearable, pain management device like Enso is not available with other musculoskeletal providers.” He emphasized that Enso provides “Both non-addictive and non-invasive pain relief” and that the “new peer-reviewed published randomized controlled clinical study finds that Hinge Health’s Enso delivers 2x more pain reduction and improves mobility 3x compared to the control group over a 4-week period.”