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

NCT07234084 | Recruiting

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

Brief 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

Keywords

Bone Stress Injury; Functional Magnetic Stimulation; Physiotherapy; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Changes in pain intensity with Numeric Rating Scale (NPRS)

  This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. Participants will be asked to rate their pain under three conditions: at rest, during standardized loading of the affected limb, and during hypothetical return to sport.The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.

  pre-treatment, week 4, Week 16

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

  The LEFS-GR is a self-reported questionnaire consisting of 20 items that assess the degree of difficulty in performing everyday and sport-related lower-limb activities. Each item is rated on a 5-point scale (0 = extreme difficulty or unable to perform; 4 = no difficulty), yielding a total score from 0 to 80, with higher scores indicating better functional ability. The Greek version of the LEFS has demonstrated excellent internal consistency (Cronbach's α = 0.974) and test-retest reliability (ICC = 0.986, p \< 0.001) in individuals with lower-limb musculoskeletal disorders (Stasi et al., 2012).

  baseline, week 4, week 16

• Changes in bone marrow edema characteristics with Magnetic Resonance Imaging (MRI)

  Magnetic Resonance Imaging (MRI) will be used to evaluate changes in bone marrow edema (BME) according to the Fredericson classification, which grades stress-related bone injury from 0 (normal) to 4 (cortical fracture). MRI scans will include T1-weighted and fat-suppressed T2/STIR sequences obtained under identical imaging parameters at all time points. Semi-quantitative analysis will be performed to record (a) Fredericson grade, (b) bone marrow edema signal intensity on a 0-3 scale, and (c) edema extent as a percentage of the total bone volume.

  baseline, week 4, week 16

• Changes in return-to-sport readiness with the Tegner Activity Scale and perceived sport pain

  The Tegner Activity Scale (TAS) is an 11-level ordinal scale designed to evaluate physical activity and sports participation following lower-limb injury. It ranges from 0 (inability to work or perform daily activities due to symptoms) to 10 (participation in competitive sports at national or elite level). The validated Greek version (Gr-TAS) demonstrates high internal consistency (Cronbach's α = 0.89) and test-retest reliability (ICC = 0.97) in musculoskeletal populations (Panagopoulos et al., 2020). In this study, the scale will be combined with a perceived sport-related pain score (NRS 0-10), where higher TAS scores and lower pain scores will indicate greater readiness to return to sport.

  baseline, week 4, week 16

Study Arms (2)

Physiotherapy plus Functional Magnetic Stimulation (FMS)

EXPERIMENTAL

Participants allocated to this group will receive 12 sessions of a conventional physiotherapy protocol and 8 sessions of FMS.

Other: Conventional Physiotherapy with FMS

Physiotherapy without Functional Magnetic Stimulation (FMS)

ACTIVE COMPARATOR

Participants allocated to this group will receive 12 sessions of a conventional physiotherapy protocol without the FMS

Other: Conventional Physiotherapy without FMS

Interventions

Conventional Physiotherapy with FMS OTHER

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.

Physiotherapy plus Functional Magnetic Stimulation (FMS)

Conventional Physiotherapy without FMS OTHER

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

Physiotherapy without Functional Magnetic Stimulation (FMS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos, 57400, Greece

RECRUITING

Study Officials

• Paris Iakovidis, PhD

  International Hellenic University

  STUDY CHAIR

Central Study Contacts

Dimitrios Lytras, PhD

CONTACT

2310013802; lytrasde@gmail.com

Paris Iakovidis, PhD

CONTACT

2310013802; paris_physio@yahoo.com

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: A single-assessor-blind randomized controlled trial lasting four weeks, with a twelve-week follow-up, will be conducted on forty athletes diagnosed with MRI-confirmed bone marrow edema of the lower limb graded as Fredericson 2 or 3. Participants will be randomly allocated into two groups of twenty each (intervention and control). The intervention group will receive a combined treatment consisting of a standardized physiotherapy rehabilitation program and Functional Magnetic Stimulation (two sessions per week for four weeks), while the control group will follow the same physiotherapy protocol without FMS. Clinical assessments of pain and functional ability will be performed at baseline, at two weeks, at the end of the four-week intervention, and at sixteen weeks to monitor short- and medium-term recovery. MRI will be conducted at baseline, week 4, and week 16 to document radiological changes in bone marrow edema.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)