RCT of Pulsed Electromagnetic Fields Plus Nutraceutical Supplementation in Women With Distal Radius Fracture
RCT of Pulsed Electromagnetic Fields Plus Nutraceutical Supplementation in Women With Distal Radius Fracture
This single-center randomized controlled trial tests whether adding a daily nutraceutical supplement to standard pulsed electromagnetic field (PEMF) therapy improves recovery after a recent distal radius (wrist) fracture in women. The study asks: does PEMF plus a supplement of vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper produce faster bone healing, greater pain relief, less soft-tissue swelling, and fewer complications (including complex regional pain syndrome) than PEMF alone? Sixty women aged 45-55 with a recent radiographically confirmed distal radius fracture and baseline pain NRS ≥ 4 are randomized 1:1. One group receives PEMF 9 hours per day for 30 days. The other group receives the same PEMF regimen plus the daily oral nutraceutical for 30 days. Assessments occur at baseline, 15 days (early ultrasound and laboratory markers), and 30 days (radiographic healing, Budapest criteria for complex regional pain syndrome, pain NRS, and functional measures).
The primary outcomes are change in pain (NRS) and early callus formation at 15 days, with radiographic healing at 30 days. Secondary outcomes include biochemical markers of bone turnover, 24-hour calciuria and phosphaturia, soft-tissue edema by ultrasound, functional recovery, safety, and tolerability. The hypothesis is that the combined treatment leads to earlier and clinically meaningful improvements in pain, function, and bone repair compared with PEMF alone.
This trial investigates whether adding a defined daily nutraceutical regimen to an established pulsed electromagnetic field (PEMF) protocol influences early biological fracture repair and short-term clinical recovery in peri-menopausal women with recent distal radius fractures; it is designed to link biochemical markers, imaging signals, device usage data, and patient-reported outcomes to test the hypothesis that targeted micronutrient support potentiates PEMF-mediated osteogenic and anti-inflammatory effects, accelerating early callus formation, reducing pain and soft-tissue swelling, and maintaining acceptable safety and tolerability. The trial employs centralized randomization, standardized visit windows, and pre-specified procedures for specimen handling, imaging acquisition, and blinded read workflows to ensure temporal comparability and measurement quality; adherence is monitored through device logs, pill counts, and participant diaries, with defined follow-up for nonadherence. Data are captured in source documents and an electronic database with validation checks, role-based access, audit trails, and QA processes including internal monitoring and independent adjudication of discordant imaging reads. The statistical framework follows intention-to-treat principles with mixed-effects models for repeated measures, pre-specified sensitivity and per-protocol analyses, and strategies for handling missing data and potential confounders; subgroup analyses explore baseline nutritional status and device usage intensity. Safety oversight includes continuous adverse event capture, graded severity and causality assessment, and predefined reporting pathways to study safety officers and the ethics committee. Ethical and regulatory compliance adheres to Good Clinical Practice and local regulations, with informed consent, participant confidentiality safeguards, GMP-compliant product handling, and procedures for protocol deviations and safety signals. Results will be reported with effect estimates and confidence intervals, interpreted for clinical relevance and biological coherence across biomarkers and imaging, and disseminated through peer-reviewed publications and lay summaries for participants and stakeholders.
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