Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Chronic low back pain is a common problem and is associated with high costs. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation (TENS) for clinical use. OBJECTIVE The present study evaluated the efficacy of EAS in patients with chronic low back pain. METHODS In this prospective, randomized, controlled double-blinded study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and received assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (Group EAS, n = 42) or sham EAS plus NSAIDs (Group NSAIDs, n = 41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at 1st, 14th, and 20th visits. RESULTS After 6 weeks of treatment, the treatment success rate (TSR) in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention to treat (ITT) and per protocol (PP) analyses, and significant differences were observed only in visit 16 in the ITT analysis (EAS group: 83.8% and NSAID group: 61.8%, P = .036). The change in the VAS score from baseline in each visit in the EAS group was higher than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in visit 5 and visit 9 in the ITT analysis (P = .048 and .048, respectively). Significant differences were observed in left rotation in visit 2 and visit 4. No significant differences were observed in the VAS score before and after treatment in each visit and in quality of life in both groups. CONCLUSIONS EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. CLINICALTRIAL ClinicalTrials.gov NCT02468297; https://clinicaltrials.gov/ct2/show/NCT02468297