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

NCT07352501 | Active Not Recruiting

• 1 other identifier: MFR052025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture of Distal Radius; Bone Fractures; Wrist Injuries

Keywords

distal radius fracture; wrist injury; pulsed electromagnetic fields; nutraceutical supplementation; bone healing; pain management; functional recovery

Outcome Measures

Primary Outcomes (1)

• Radiographic fracture healing (proportion with cortical bridging) at 30 days

  30 days post-intervention

Study Arms (2)

PEMF therapy alone (standard care)

ACTIVE COMPARATOR

Device: Pulsed Electromagnetic Field Therapy

PEMF therapy + daily nutraceutical supplementation

EXPERIMENTAL

Device: Pulsed Electromagnetic Field Therapy; Dietary Supplement: Nutraceutical Supplement

Interventions

Pulsed Electromagnetic Field Therapy DEVICE

9 hours per day for 30 consecutive days using a wearable PEMF device

PEMF therapy + daily nutraceutical supplementation; PEMF therapy alone (standard care)

Nutraceutical Supplement DIETARY_SUPPLEMENT

Daily oral dose containing vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper for 30 days

PEMF therapy + daily nutraceutical supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

A.O.U.P. Paolo Giaccone

Palermo, Italy, 90127, Italy

Location

MeSH Terms

Conditions

Fractures, Bone; Wrist Injuries; Wrist Fractures; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arm Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 20, 2026
• Study Start: March 10, 2025
• Primary Completion: August 20, 2025
• Study Completion: March 15, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-10

Locations

IT (1)