The Effects of Novel Pulsed Electromagnetic Field Therapy Device on Acute Distal Radius Fractures: A Prospective, Double-Blind, Sham-Controlled, Randomized Pilot Study

Background: this pilot study aimed at determining whether the application of a novel new method of generating pulsed electromagnetic field (PEMF), the Fracture Healing Patch (FHP), accelerates the healing of acute distal radius fractures (DRF) when compared to a sham treatment. Methods: 41 patients with DRFs treated with cast immobilization were included. Patients were allocated to a PEMF group (n = 20) or a control (sham) group (n = 21). All patients were assessed with regard to functional and radiological outcomes (X-rays and CT scans) at 2, 4, 6 and 12 weeks. Results: fractures treated with active PEMF demonstrated significantly higher extent of union at 4 weeks as assessed by CT (76% vs. 58%, p = 0.02). SF12 mean physical score was significantly higher in PEMF treated group (47 vs. 36, p = 0.005). Time to cast removal was significantly shorter in PEMF treated patients, 33 +/- 5.9 days in PEMF vs. 39.8 +/- 7.4 days in sham group (p = 0.002). Conclusion: early addition of PEMF treatment may accelerate bone healing which could lead to a shorter cast immobilization, thus allowing an earlier return to daily life activities and work. There were no complications related to the PEMF device (FHP).

Automated summary

This study aimed to determine if the application of a novel method of generating pulsed electromagnetic field (PEMF), called the Fracture Healing Patch (FHP), can accelerate the healing of acute distal radius fractures (DRF) compared to a sham treatment. The results showed that fractures treated with active PEMF had a significantly higher union rate at 4 weeks, as assessed by CT scans. The PEMF treated group also had significantly higher physical scores and shorter time to cast removal. The early addition of PEMF treatment can accelerate bone healing and lead to a shorter cast immobilization, allowing for an earlier return to daily activities and work. There were no complications related to the PEMF device (FHP).