CompletedNot Applicable

Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes

Greece40 participantsStarted 2025-12-01

Plain-language summary

This randomized controlled trial evaluates whether Functional Magnetic Stimulation (FMS) can provide additional benefits when combined with a structured physiotherapy rehabilitation program in athletes with MRI-confirmed tibial bone stress injury and associated bone marrow edema. A total of 40 athletes with Fredericson grade 2 or 3 lesions are allocated to either a combined intervention group receiving FMS plus rehabilitation or a control group receiving rehabilitation alone. The intervention period lasts four weeks. Participants in both groups follow the same load-based rehabilitation program, while those in the FMS group also receive eight 30-minute FMS sessions. Assessments are performed at baseline, after the four-week intervention, and at 16 weeks. The evaluated outcomes include activity-related tibial pain, lower-limb functional ability, MRI-measured bone marrow edema extent, and Fredericson MRI grade. The purpose of the study is to examine whether adding FMS to standardized rehabilitation leads to greater clinical, functional, and MRI-derived improvement compared with rehabilitation alone.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 45 years. * Regular participation in sports training at least three times per week during the previous six months. * MRI-confirmed tibial bone stress injury classified as Fredericson grade 2 or grade 3. * Localized tibial pain provoked by loading activity. * Activity-related pain intensity of at least 3/10 on the Numeric Pain Rating Scale. * Written informed consent provided before participation. Exclusion Criteria: * Fredericson grade 4 injury or visible fracture line on MRI. * Bone marrow edema related to infection, tumor, systemic inflammatory disease, or another non-mechanical cause. * History of fracture, surgery, or intra-articular/peri-osseous injection in the affected lower limb within the previous 12 weeks. * Previous Functional Magnetic Stimulation or Extracorporeal Shockwave Therapy within the previous 8 weeks. * Contraindications to magnetic stimulation, including pacemaker, implanted neurostimulator, cochlear implant, or significant metallic implant in or near the treatment area. * Pregnancy or breastfeeding. * Any neurological, metabolic, cardiovascular, or systemic condition that could affect safe participation or interpretation of study outcomes.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in tibial pain during a standardized walking task

Timeframe: baseline, week 4, week 16

Trial details

NCT IDNCT07234084

SponsorInternational Hellenic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-29

View on ClinicalTrials.gov More Bone Marrow Edema trials