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

NCT07234084 | Completed

• 1 other identifier: EC-15/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Marrow Edema

Keywords

Functional Magnetic Stimulation; Physiotherapy; Rehabilitation; Tibial Bone Stress Injury

Outcome Measures

Primary Outcomes (1)

• Change in tibial pain during a standardized walking task

  Description: Pain related to loading of the affected tibia is measured with the Numeric Pain Rating Scale, an 11-point scale ranging from 0 to 10. A score of 0 indicates absence of pain, while a score of 10 indicates the highest possible pain intensity. At each assessment, participants complete a standardized treadmill walking task and report the greatest tibial pain experienced during the test. The walking speed selected at the initial assessment is kept the same for each participant at follow-up measurements, allowing pain to be evaluated under comparable loading conditions. Higher scores reflect greater symptom severity.

  baseline, week 4, week 16

Secondary Outcomes (3)

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

  baseline, week 4, week 16

• Change in MRI-derived bone marrow edema extent

  baseline, week 4, week 16

• Change in Fredericson MRI grade

  baseline, week 4, week 16

Study Arms (2)

Functional Magnetic Stimulation plus standardized physiotherapy rehabilitation

EXPERIMENTAL

Arm Description: Participants receive 12 physiotherapy rehabilitation sessions over four weeks plus eight 30-minute FMS sessions applied over the symptomatic tibial region.

Other: Standardized physiotherapy rehabilitation with FMS

Physiotherapy rehabilitation alone

ACTIVE COMPARATOR

Participants in this group complete 12 supervised physiotherapy rehabilitation sessions over a four-week period and do not receive Functional Magnetic Stimulation.

Other: Standardized Physiotherapy without FMS

Interventions

Standardized physiotherapy rehabilitation with FMS OTHER

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.

Functional Magnetic Stimulation plus standardized physiotherapy rehabilitation

Standardized Physiotherapy without FMS OTHER

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

Physiotherapy rehabilitation alone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years.
• Regular participation in sports training at least three times per week during the previous six months.
• MRI-confirmed tibial bone stress injury classified as Fredericson grade 2 or grade 3.
• Localized tibial pain provoked by loading activity.
• Activity-related pain intensity of at least 3/10 on the Numeric Pain Rating Scale.
• Written informed consent provided before participation.

You may not qualify if:

• Fredericson grade 4 injury or visible fracture line on MRI.
• Bone marrow edema related to infection, tumor, systemic inflammatory disease, or another non-mechanical cause.
• History of fracture, surgery, or intra-articular/peri-osseous injection in the affected lower limb within the previous 12 weeks.
• Previous Functional Magnetic Stimulation or Extracorporeal Shockwave Therapy within the previous 8 weeks.
• Contraindications to magnetic stimulation, including pacemaker, implanted neurostimulator, cochlear implant, or significant metallic implant in or near the treatment area.
• Pregnancy or breastfeeding.
• Any neurological, metabolic, cardiovascular, or systemic condition that could affect safe participation or interpretation of study outcomes.

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos, 57400, Greece

Location

Study Officials

• Paris Iakovidis, PhD

  International Hellenic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A masked assessor will conduct the measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Model Details: This is a single-assessor-blinded randomized controlled trial including 40 athletes with MRI-confirmed Fredericson grade 2 or 3 tibial bone stress injury. Participants are randomly allocated to either FMS plus standardized physiotherapy rehabilitation or physiotherapy rehabilitation alone. Both groups complete a four-week load-based rehabilitation program, while the FMS group additionally receives eight FMS sessions over four weeks. Outcomes are assessed at baseline, week 4, and week 16, including activity-related tibial pain, lower-limb function, bone marrow edema extent, and Fredericson MRI grade.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion: June 29, 2026
• Study Completion: June 29, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)