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 range18 Years – 45 Years

SexALL

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.

What they're measuring

Changes in pain intensity with Numeric Rating Scale (NPRS)

Timeframe: pre-treatment, week 4, Week 16

Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)

Timeframe: baseline, week 4, week 16

Changes in bone marrow edema characteristics with Magnetic Resonance Imaging (MRI)

Timeframe: baseline, week 4, week 16

Changes in return-to-sport readiness with the Tegner Activity Scale and perceived sport pain

Timeframe: baseline, week 4, week 16

Trial details

NCT IDNCT07234084

SponsorInternational Hellenic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-15

Contact for this trial

Dimitrios Lytras, PhD

2310013802 lytrasde@gmail.com

View on ClinicalTrials.gov More Bone Marrow Edema trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

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

What they're measuring

Changes in pain intensity with Numeric Rating Scale (NPRS)

Timeframe: pre-treatment, week 4, Week 16

Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)

Timeframe: baseline, week 4, week 16

Changes in bone marrow edema characteristics with Magnetic Resonance Imaging (MRI)

Timeframe: baseline, week 4, week 16

Changes in return-to-sport readiness with the Tegner Activity Scale and perceived sport pain

Timeframe: baseline, week 4, week 16