Effectiveness of Pulsed Electromagnetic Fields and Nutraceutical Supplementation in Women With Distal Radius Fracture

January 13, 2026 updated by: Prof.ssa Giulia Letizia Mauro, University of Palermo

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Palermo, Italy, Italy, 90127
        • A.O.U.P. Paolo Giaccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participants aged
  • Radiographically confirmed distal radius fracture within 5 days of trauma
  • Presentation to the hospital within 3 days of the fracture event
  • Fracture treated conservatively with a cast (non-surgical management)
  • Baseline pain score ≥ 4 on the Numeric Rating Scale (NRS)
  • Ability to provide informed consent
  • Willingness to comply with study procedures and follow-up visits

Exclusion Criteria:

  • Bilateral wrist fractures
  • Prior surgery on the affected wrist
  • Use of bone-active medications (e.g., bisphosphonates, corticosteroids) in the past 6 months
  • Known allergy or intolerance to any component of the nutraceutical supplement
  • Presence of implanted electronic devices (e.g., pacemaker)
  • Cognitive impairment or psychiatric condition interfering with consent or adherence
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEMF therapy alone (standard care)
Device: Pulsed Electromagnetic Field Therapy
9 hours per day for 30 consecutive days using a wearable PEMF device
Experimental: PEMF therapy + daily nutraceutical supplementation
Device: Pulsed Electromagnetic Field Therapy
9 hours per day for 30 consecutive days using a wearable PEMF device
Dietary supplement: Nutraceutical Supplement
Daily oral dose containing vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic fracture healing (proportion with cortical bridging) at 30 days
Time Frame: 30 days post-intervention
30 days post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

August 20, 2025

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFR052025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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