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

NCT07234084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Bone Marrow Edema

Interventions

OTHER

Conventional Physiotherapy with FMS

Participants will receive a standardized four-week physiotherapy program, three sessions per week (12 sessions in total), each lasting approximately 45 minutes. Treatment will include therapeutic exercise for progressive strengthening and flexibility, manual therapy for pain modulation, and unloading-reloading strategies to restore functional load tolerance. Exercises will be tailored to the recovery stage, and participants will be instructed on home exercises and activity modification. In addition, participants will receive Functional Magnetic Stimulation (FMS) twice weekly for four weeks (eight sessions in total). Each session will last 30 minutes. FMS will be applied directly over the affected region using a fixed frequency of 40 Hz without modulation. The stimulation duty cycle will consist of an active phase of 3 seconds followed by a rest period of 6 seconds. Intensity will be gradually adjusted to patient tolerance avoding scomfort or excessive contraction.

OTHER

Conventional Physiotherapy without FMS

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

Sponsors & Collaborators

  • International Hellenic University

    lead OTHER

Principal Investigators

  • Paris Iakovidis, PhD · International Hellenic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-09-15
Completion
2026-09-15

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234084 on ClinicalTrials.gov