High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study

Abstract

Purpose This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP). Methods A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann–Whitney U -test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time. Results The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen’s d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05). Conclusion A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.

Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks

“…The Oura ring can accurately measure sleep time, sleep onset latency, time spent in deep and light sleep, and wake after sleep onset [ 53 ]. Digital health products also include non-invasive vagal nerve stimulators, such as Nurosym, or Hinge Health Enso, a wearable that delivers high-frequency impulse therapy for pain [ 54 ]. Table 1 provides examples of DTx and other digital health and wellness technologies that can improve health outcomes.…”

Effectiveness of Hybrid Form Impulse Therapy (HFIT) Compared to Traditional Transcutaneous Electronic Nerve Stimulation (TENS) in Patients with Chronic Low Back and Knee Pain: A Randomized Controlled Trial

“…A feasibility randomized controlled trial (RCT) found that HFIT provided a significant improvement in pain and function in comparison to a sham device among patients with chronic low back pain after four weeks. 20 However, little is known about how HFIT performs against traditional TENS. As a result, this study aimed to examine whether HFIT provided improvement in pain and function in comparison to traditional TENS and usual care among participants of a digital chronic MSK program with knee and low back pain.…”