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| The effects of novel pulsed electromagnetic field therapy device on acute distal radius fractures: a prospective, double-blind, sham-controlled, randomized pilot study |
| Factor S, Druckmann I, Atlan F, Rosenblatt Y, Tordjman D, Krespi R, Kazum E, Pritsch T, Eisenberg G |
| Journal of Clinical Medicine 2023 Feb;12(5):1866 |
| clinical trial |
| 9/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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% versus 58%, p = 0.02). SF12 mean physical score was significantly higher in PEMF treated group (47 versus 36, p = 0.005). Time to cast removal was significantly shorter in PEMF treated patients, 33 +/- 5.9 days in PEMF versus 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).
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