Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes (NCT07234084) | Clinical Trial Compass
RecruitingNot Applicable
Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes
Greece40 participantsStarted 2025-11-15
Plain-language summary
This randomized controlled trial investigates the effectiveness of Functional Magnetic Stimulation (FMS) as an adjunct to physiotherapy in athletes with MRI-confirmed bone marrow edema of the lower limb. Forty athletes with Fredericson grade 2-3 edema will be randomly assigned to receive either physiotherapy plus FMS or physiotherapy alone for four weeks. Clinical, functional, and imaging assessments will be conducted up to 16 weeks. Primary outcomes include pain intensity, lower-limb function, return-to-sport readiness, and MRI indicators of bone marrow edema. The study aims to determine whether adjunctive FMS enhances recovery and accelerates the resolution of bone marrow edema compared with standard physiotherapy.
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:
* Athletes aged 18-45 years participating in regular sports training ≥3 sessions per week for the past 6 months.
* MRI-confirmed bone marrow edema (BME) of the lower limb graded as Fredericson 2 or 3.
* Onset of pain or symptoms within the previous 6 weeks.
* Pain intensity ≥4/10 on the Numeric Rating Scale during loading activity.
* Ability to comply with the 4-week intervention and 16-week follow-up assessments.
* Written informed consent provided prior to participation.
Exclusion Criteria:
* Fredericson grade 4 or evidence of a fracture line on MRI. Bone marrow edema secondary to infection, tumor, or systemic inflammatory disease.
* History of recent fracture, surgery, or intra-articular injection in the affected limb within 12 weeks.
* Prior exposure to Functional Magnetic Stimulation or Extracorporeal Shockwave Therapy within 8 weeks before enrollment.
* Presence of metallic implants, pacemaker, or other contraindications to magnetic stimulation.
Pregnancy or breastfeeding. Use of systemic corticosteroids or medications affecting bone metabolism. Any neurological, metabolic, or cardiovascular condition interfering with safe participation.
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
1
Changes in pain intensity with Numeric Rating Scale (NPRS)
Timeframe: pre-treatment, week 4, Week 16
2
Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)
Timeframe: baseline, week 4, week 16
3
Changes in bone marrow edema characteristics with Magnetic Resonance Imaging (MRI)
Timeframe: baseline, week 4, week 16
4
Changes in return-to-sport readiness with the Tegner Activity Scale and perceived sport pain