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COMPLETED
NCT07234084
NA

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

Sponsor: International Hellenic University

View on ClinicalTrials.gov

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.

Official title: The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-12-01

Completion Date

2026-06-29

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

OTHER

Standardized physiotherapy rehabilitation with FMS

Participants in this arm complete a supervised four-week rehabilitation program delivered three times per week, for a total of 12 sessions of approximately 45 minutes each. The program focuses on symptom-guided activity modification, progressive lower-limb loading, strengthening, mobility exercises, neuromuscular control, home-based exercise guidance, and gradual return to impact-related activity. In addition, participants receive Functional Magnetic Stimulation twice per week for four weeks, resulting in eight sessions in total. Each FMS session lasts 30 minutes and is applied over the symptomatic tibial region. Stimulation is delivered at 40 Hz, with repeated cycles of 3 seconds of stimulation followed by 6 seconds of rest. Intensity is increased gradually according to participant tolerance, while avoiding pain, excessive discomfort, or overly strong muscle contractions.

OTHER

Standardized Physiotherapy without FMS

Participants in this group will follow the same standardized physiotherapy protocol as the first group, without the application of FMS

Locations (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos, Greece