Functional Magnetic Stimulation combined with physiotherapy for lower‑limb bone marrow edema in athletes
The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial
This trial tests whether adding Functional Magnetic Stimulation to standard physiotherapy helps athletes with MRI‑confirmed lower‑limb bone marrow edema recover faster, have less pain, and return to sport sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | International Hellenic University Academic / other |
| Locations | 1 site (Thessaloniki, Sindos) |
| Trial ID | NCT07234084 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial will enroll 40 athletes with Fredericson grade 2–3 lower‑limb bone marrow edema and randomly assign them to four weeks of structured physiotherapy with or without adjunctive Functional Magnetic Stimulation (FMS). FMS is a non‑invasive technique that produces deep neuromuscular activation and may improve local circulation and tissue recovery. Clinical, functional, and MRI assessments—including pain scores, lower‑limb function tests, return‑to‑sport readiness, and MRI edema measures—will be performed up to 16 weeks. The trial compares clinical recovery speed and radiological resolution of edema between the two groups.
Who should consider this trial
Good fit: Ideal candidates are athletes aged 18–45 who train at least three times per week, have MRI‑confirmed Fredericson grade 2–3 lower‑limb bone marrow edema with symptom onset within the past 6 weeks and pain ≥4/10, and can complete the four‑week program and 16‑week follow‑up.
Not a fit: Patients with Fredericson grade 4 changes or a fracture line, bone marrow edema from infection, tumor, or systemic inflammatory disease, recent fracture/surgery or intra‑articular injection, recent FMS/ESWT exposure, metallic implants or pacemakers, or pregnancy are unlikely to be eligible and may not benefit.
Why it matters
Potential benefit: If effective, adjunctive FMS could shorten recovery time, reduce pain, and help athletes return to sport sooner while promoting faster MRI resolution of bone marrow edema.
How similar studies have performed: FMS has shown promise in other musculoskeletal rehabilitation contexts for improving muscle activation and circulation, but randomized controlled evidence for treating bone marrow edema specifically is lacking, making this a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Thessaloniki, Sindos
- Department of Physiotherapy, Faculty of Health Sciences International Hellenic University — Thessaloniki, Sindos, Greece (Recruiting)
Study contacts
- Study coordinator: Dimitrios Lytras, PhD
- Email: lytrasde@gmail.com
- Phone: 2310013802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.