Low-intensity Continuous Ultrasound Alleviates Symptoms Of Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled Trial

PURPOSE: Chronic low back pain (CLBP) affects 23.3% of the US population, with increasing prevalence due to the increasing older population, leading to disability and socioeconomic burden on the US economy. Low-intensity continuous ultrasound (LICUS) provides a non-invasive, non-pharmacological method for managing CLBP by delivering a mechanical stimulus. This study determines the impact of a long-duration LICUS treatment on the lower spinal column to alleviate pain and improve the quality of life in comparison to placebo treatment. METHODS: Sixty-five participants (n = 26 male, n = 39 female), 47.0 ± 13.9 years of age, with CBLP for more than 3 months, were randomly assigned to LICUS (n = 33) or placebo (n = 32) treatment. Baseline pain levels and medication usage were recorded over 2 weeks before treatment. Participants underwent daily 4-hour lower lumbar region treatment with either active or placebo treatment for 8 weeks. Participants maintained daily diaries, reporting biweekly pain levels on the numeric rating scale (NRS, 0-10), Global Rating of Change (GROC), medication reduction, physical activity, and functionality to assess patient satisfaction. RESULTS: No significant differences in baseline pain levels or demographic characteristics were observed between the two groups. In the LICUS-treated group, 76% (n = 25) and 50% of the placebo group (n = 16) completed the study. No serious adverse events were reported. The LICUS-treated group exhibited a significant reduction of 2.30-3.15 NRS scale at 2, 4, 6, and 8 weeks relative to the placebo group (p < 0.0001). The most pain reduction was recorded in the first 2 weeks, followed by a gradual decrease over the next 6 weeks. At the 8-week mark, the LICUS-treated group demonstrated a mean reduction of 2.57 points on the NRS scale (95% CI: 3.46 to 1.69, p < 0.0001), a 3.48 GROC score improvement (95% CI: 2.71 to 4.24, p < 0.0001) was recorded relative to the placebo group, along with a significantly lower difference of 22.5% mean daily medication use of 15.2 morphine mg equivalent (MME) dosage (95% CI: 10.9% to 34.1%, p = 0.0004) for the active LICUS group. CONCLUSIONS: Daily LICUS treatment significantly alleviates clinical symptoms of CLBP relative to placebo treatment. LICUS is a safe and non-invasive therapeutic option for patients with CLBP. The National Space Biomedical Research Institute (NSBRI)