RecruitingNot ApplicableNCT07234084

Functional Magnetic Stimulation (FMS) for 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


Sponsor

International Hellenic University

Enrollment

40 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

OTHERConventional 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.

OTHERConventional Physiotherapy without FMS

Participants in this group will follow the same conventional 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

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NCT07234084


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