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

Abstract

Background Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. 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 for clinical use. Objective The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. Methods In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, 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 the 2nd, 14th, and 20th visits. Results After 6 weeks of treatment, the treatment success rate 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, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the 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. Trial Registration ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297

Neuropathic Pain Creates Systemic Ultrastructural Changes in the Nervous System Corrected by Electroacupuncture but Not by Pregabalin

“…These results imply that neuromodulation techniques have additional advantages when compared to a pharmacologic approach in the treatment of chronic pain. EA, a therapeutic means based on acupuncture combined with electrical stimulation, 39 has proven effective in pain relief 40 and multiple organ protection. 41 Parmen et al 42 showed that EA can facilitate an improvement in tissue mechanical stress and enhance the wound healing process without detrimental side effects.…”

Acupuncture as complementary treatment for lower back pain

“…The pain was assessed at the first visit at the clinic, before and after each EAS treatment, and at 2 weeks after the last treatment. Better results in both analgesic effect and treatment success were obtained in the experimental group, proving that electronic acupuncture shoes could be considered a good alternative treatment for patients with CLBP, who for some reason cannot or do not want to be treated with NSAIDs [18].…”

Garments and Footwear for Chronic Pain

“…This device combines acupuncture and transcutaneous electrical nerve stimulation, both of which are already in clinical use. A 6-week treatment protocol indicated that the use of this therapeutic footwear had better treatment success than non-steroidal anti-inflammatory administration ( 33 ).…”