A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial

Anthony J Lisi, Mickey Scheinowitz, Richard Saporito, Anthony Onorato, Anthony J Lisi, Mickey Scheinowitz, Richard Saporito, Anthony Onorato

Abstract

Introduction: Low back pain (LBP) poses a significant burden of disease worldwide, and identifying safe and effective non-pharmacologic treatment options for LBP is a research priority. The aim of this study was to pilot a clinical trial of a portable pulsed electromagnetic field (PEMF) therapy device for subjects with mixed duration non-specific LBP.

Methods: This work was a randomized, double-blind, sham-controlled, parallel-group study conducted at a chiropractic school outpatient clinic. The primary end point was functional capacity measured by the Oswestry Disability Index (ODI) at baseline, 6 weeks, and 12 weeks. Analysis was conducted on the intent-to-treat population and as a trend of change in pain scores over time using the Freidman test of repeated measures.

Results: Forty-two participants were randomized to receive usual care plus PEMF therapy or usual care plus sham, and 25 completed the study. Significant improvements in ODI scores from baseline to week 6 were reported in the experimental group (χ2 = 14.68, p < 0.001, compared with patients in the sham group, χ2 = 4.00, p = 0.135, n.s.). This difference persisted at week-12 follow-up. Adverse events were rare and mild.

Conclusion: It is feasible to conduct a clinical trial of a PEMF therapy device for non-specific LBP. This work shows that the device was safe and provides preliminary evidence of effectiveness in improving function in patients with non-specific LBP.

Trial registration: ClinicalTrials.gov identifier, NCT03053375.

Funding: Aerotel Ltd.

Keywords: Electromagnetic fields; Low back pain; Pilot randomized controlled trial.

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
Oswestry disability index scores
Fig. 3
Fig. 3
Numerical rating scale scores

References

    1. Hoy D, March L, Brooks P, Blyth F, Woolf A, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968–974.
    1. Hurwitz EL, Randhawa K, Yu H, Côté P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018;27(Suppl 6):796–801.
    1. van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, et al. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006;15(Suppl 2):S169 ± 91.
    1. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482–491.
    1. Qaseem A, Wilt TJ, McLean RM, Forciea MA, Clinical Guidelines Committee of the American College of Physicians Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514–530.
    1. Haldeman S, Dagenais S. A supermarket approach to the evidence-informed management of chronic low back pain. Spine J. 2008;8(1):1–7.
    1. Koes BW, Van Tulder M, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006;332(7555):1430–1434.
    1. Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids compared with placebo or other treatments for chronic low back pain: an update of the Cochrane Review. Spine (Phila Pa 1976). 2014;39(7):556–563.
    1. Seth P, Scholl L, Rudd RA, Bacon S. Overdose deaths involving opioids, cocaine, and psychostimulants—United States, 2015–2016. MMWR Morb Mortal Wkly Rep. 2018;67(12):349–358.
    1. IOM (Institute of Medicine). Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press; 2011.
    1. Bose B. Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation. Adv Ther. 2001;18(1):12–20.
    1. Foley KT, Mroz TE, Arnold PM, Chandler HC, Jr, Dixon RA, Girasole GJ, Renkens KL, Jr, Riew KD, Sasso RC, Smith RC, Tung H, Wecht DA, Whiting DM. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008;8(3):436–442.
    1. Hedén P, Pilla AA. Effects of pulsed electromagnetic fields on postoperative pain: a double-blind randomized pilot study in breast augmentation patients. Aesthetic Plast Surg. 2008;32(4):660–666.
    1. Harper WL, Schmidt WK, Kubat NJ, Isenberg RA. An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain. Int Med Case Rep J. 2014;8:13–22.
    1. Oke KI, Umebese PF. Evaluation of the efficacy of pulsed electromagnetic therapy in the treatment of back pain: a randomized controlled trial in a tertiary hospital in Nigeria. West Indian Med J. 2013;62(3):205–209.
    1. Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CW, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Ostelo RW. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24(6):1127–1142.
    1. Chiarotto A, Terwee CB, Ostelo RW. Choosing the right outcome measurement instruments for patients with low back pain. Best Pract Res Clin Rheumatol. 2016;30(6):1003–1020.
    1. Pena-Philippides JC, Yang Y, Bragina O, Hagberg S, Nemoto E, Roitbak T. Effect of pulsed electromagnetic field (PEMF) on infarct size and inflammation after cerebral ischemia in mice. Transl Stroke Res. 2014;5(4):491–500.
    1. Aaron RK, Boyan BD, Ciombor DM, Schwartz Z, Simon BJ. Stimulation of growth factor synthesis by electric and electromagnetic fields. Clin Orthop Relat Res. 2004;419:30–37.
    1. De Mattei M, Caruso A, Pezzetti F, et al. Effects of pulsed electromagnetic fields on human articular chondrocyte proliferation. Connect Tissue Res. 2001;42(4):269–279.
    1. Chou L, Ellis L, Papandony M, Seneviwickrama KLMD, Cicuttini FM, Sullivan K, Teichtahl AJ, Wang Y, Briggs AM, Wluka AE. Patients’ perceived needs of osteoarthritis health information: a systematic scoping review. PLoS One. 2018;13(4):e0195489.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren