NCT07234084

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: International Hellenic University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Bone marrow edema is a reversible stress-related bone injury in athletes, causing localized pain during loading and confirmed by MRI, the gold standard for diagnosis and monitoring. Grades 2 and 3 of the Fredericson classification represent clinically significant edema without a fracture line and are managed conservatively through physiotherapy including exercise, manual techniques, and gradual reloading. Functional Magnetic Stimulation (FMS) is a non-invasive method that induces deep neuromuscular activation and improves circulation. Although increasingly used in musculoskeletal rehabilitation, its effect on recovery from bone marrow edema has not yet been tested in a controlled clinical setting. Aim: The aim of the present randomized controlled clinical trial is to evaluate the effectiveness of adding Functional Magnetic Stimulation to a structured physiotherapy rehabilitation program in athletes with MRI-confirmed bone marrow edema of the lower limb. The primary objective is to determine whether the combined approach results in greater clinical improvement, superior functional recovery, and faster radiological resolution of edema compared with physiotherapy alone. Method: Forty athletes with lower-limb bone marrow edema graded as Fredericson 2 or 3 on MRI will be randomly assigned to two groups. The intervention group will follow a four-week physiotherapy program combining therapeutic exercise, manual therapy, and unloading techniques with Functional Magnetic Stimulation applied twice weekly. The control group will receive the same physiotherapy without FMS. Assessments will occur at baseline, two, four, and sixteen weeks, including pain (NRS 0-10), functional ability (LEFS-GR), and readiness for return to sport (Tegner scale). MRI at baseline, week 4, and week 16 will evaluate Fredericson grade, edema intensity, and edema extent. All parameters are predefined as primary outcomes. Data will be analyzed with mixed-model ANOVA for repeated measures with the significance level set at p \< .05. Expected Results: It is anticipated that athletes receiving Functional Magnetic Stimulation in addition to physiotherapy will show greater pain reduction, improved lower-limb function, faster MRI-documented resolution of bone marrow edema, and earlier readiness to return to sport compared with physiotherapy alone.

Conditions

• Bone Marrow Edema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-09-15
• Completion: 2026-09-15
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Greece