Pulsed electromagnetic therapy for painful diabetic polyneuropathy: results of a double-blind randomized controlled trial

Aims: The objective of this study was to evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) on pain reduction in painful diabetic distal symmetric peripheral neuropathy (DSPN).

Methods: This was a multicentre, randomized, sham-controlled, double-blinded clinical trial evaluating PEMF therapy in painful DSPN. In this trial, participants with diabetes, DSPN (based on a Toronto Clinical Neuropathy Scoring System of >/= 6), lower extremity pain (based on an 11-point Numerical Pain Rating Scale (NPRS) of >4 and <9) and ability to complete >70% of electronic patient-reported outcome (ePRO) assessments during a 14-day run-in phase were enrolled and randomized 1:1 to self-administered bilateral PEMF (pulse duration of 42 +/- 4 microseconds repeating every 1000 +/- 25 microseconds) or sham therapy for 30 minutes twice daily for 18 weeks. The primary outcome measure was pain over the past 24 hours based on NPRS measured in an ePRO diary. The secondary outcome measure was foot skin perfusion pressure (SPP). Participant technology errors [low field strength alerts (LFSN)] were also captured throughout the trial.

Results: A total of 182 (n=92 PEMF; n=90 Sham) participants with similar demographics were enrolled and received at least one PEMF or Sham treatment. Of these, 164 (n=81 PEMF; n=83 sham) completed the treatment protocol. For the primary outcome of pain reduction (assessed as a 2-point reduction in NPRS scores and a 30% pain reduction by NPRS at 17 weeks), the LFSN-free PEMF arm (n=46) had statistically significant improvement compared to the Sham arm. For the secondary outcome, there was no statistically significant differences in SPP between arms.

Conclusions: The investigators concluded that PEMF therapy is an effective therapy to reduce pain in individuals with painful DSPN.

Comments: In this study, PEMF was evaluated for the treatment of painful DSPN in a sham-controlled, randomized controlled trial. Painful DSPN has significant negative impacts on both physical functioning and quality-of-life (Pouwer F et al. Diabetes Care 2024;47:17-25) and currently available pharmacotherapy treatments options are limited (Pop-Busui R et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. American Diabetes Association Clinical Compendia; 2022). In this current study, a novel non-invasive treatment (home-based PEMF) was evaluated for painful DSPN and found to be superior for pain reduction compared to Sham treatment. Although this study was sham-controlled, there are several methodologic limitations that potentially significantly confound the results of this trial due to selection bias. For example, study enrolment was predicated on the ability to complete pain outcome measures electronically. Additionally, only participants who did not experience any PEMF device errors were analysed for the primary outcome of pain reduction. Further studies should be conducted prior to definitively concluding PEMF is effective for pain reduction in painful DSPN.

Kara Mizokami-Stout

Reference: Tassone EE, Page JC, Slepian MJ. Assessing the Effects of Pulsed Electromagnetic Therapy on Painful Diabetic Distal Symmetric Peripheral Neuropathy: A Double-Blind Randomized Controlled Trial. J Diabetes Sci Technol. 2025 Mar;19(2):361-369. doi: 10.1177/19322968231190413. Epub 2023 Aug 4. PMID: 37542366; PMCID: PMC11874150.

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