Fracture of Distal RadiusNCT07352501
Effectiveness of Pulsed Electromagnetic Fields and Nutraceutical Supplementation in Women With Distal Radius Fracture
A study testing Pulsed Electromagnetic Field Therapy and Nutraceutical Supplement in people with Fracture of Distal Radius and Bone Fractures, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fracture of Distal Radius, Bone Fractures, Wrist Injuries
- What is being tested?
- Pulsed Electromagnetic Field Therapy and Nutraceutical Supplement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fracture of Distal Radius, Bone Fractures, Wrist Injuries
- Being tested
- Pulsed Electromagnetic Field Therapy, Nutraceutical Supplement
- Keywords
- distal radius fracture, wrist injury, pulsed electromagnetic fields, nutraceutical supplementation, bone healing, pain management, functional recovery
- Medical subject headings
- Fractures, Bone, Wrist Injuries, Wrist Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field TherapyDevice
9 hours per day for 30 consecutive days using a wearable PEMF device
Nutraceutical SupplementDietary supplement
Daily oral dose containing vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper for 30 days
| Study group | Role | What they receive |
|---|---|---|
| PEMF therapy alone (standard care) | Active comparator | Not described Receives: Device: Pulsed Electromagnetic Field Therapy |
| PEMF therapy + daily nutraceutical supplementation | Experimental | Not described Receives: Device: Pulsed Electromagnetic Field Therapy; Dietary Supplement: Nutraceutical Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic fracture healing (proportion with cortical bridging) at 30 days
Measured: 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 Mar 2025
- Primary completion20 Aug 2025
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Distal RadiusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352501
- Sponsor's protocol ID
- MFR052025
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Pulsed Electromagnetic Fields Plus Nutraceutical Supplementation in Women With Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT07352501
- Acronym / sponsor ID
- MFR052025
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field Therapy9 hours per day for 30 consecutive days using a wearable PEMF device | Device | PEMF therapy + daily nutraceutical supplementation, PEMF therapy alone (standard care) |
| Nutraceutical SupplementDaily oral dose containing vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper for 30 days | Dietary supplement | PEMF therapy + daily nutraceutical supplementation |
Primary outcome
Radiographic fracture healing (proportion with cortical bridging) at 30 days
Time frame: 30 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field Therapy and Nutraceutical Supplement in people with Fracture of Distal Radius and Bone Fractures, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic fracture healing (proportion with cortical bridging) at 30 days (time frame: 30 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.