Bone Marrow EdemaNCT07234084
Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes
A study testing Standardized physiotherapy rehabilitation with FMS and Standardized Physiotherapy without FMS in people with Bone Marrow Edema, run by International Hellenic University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- Standardized physiotherapy rehabilitation with FMS and Standardized Physiotherapy without FMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
Thessaloniki, Sindos, 57400
About this study
Official title: The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial
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.
Read the detailed description
Background: Tibial bone stress injury is a clinically relevant overuse condition in athletes and is commonly associated with bone marrow edema on magnetic resonance imaging. It typically presents with localized tibial pain during weight-bearing or sport-related loading and may interfere with training participation and return to activity. MRI is used to confirm the diagnosis, determine injury severity, and monitor structural recovery. Fredericson grades 2 and 3 represent tibial bone stress injuries with bone marrow edema but without a visible fracture line, and are usually treated conservatively through activity modification, graded loading, therapeutic exercise, and progressive rehabilitation. Functional Magnetic Stimulation (FMS) is a non-invasive electromagnetic intervention that can induce deep neuromuscular activation and may contribute to pain modulation, improved load tolerance, and local tissue responses. However, its role as an adjunctive intervention in athletes with MRI-confirmed tibial bone stress injury remains insufficiently investigated.
Aim: The aim of this randomized controlled clinical trial is to evaluate whether adding Functional Magnetic Stimulation to a standardized physiotherapy rehabilitation program provides additional benefits in athletes with MRI-confirmed tibial bone stress injury associated with bone marrow edema. The study examines whether the combined intervention leads to greater improvement in activity-related pain, lower-limb functional ability, and MRI-derived indicators of recovery compared with standardized rehabilitation alone.
Method: Forty athletes with MRI-confirmed tibial bone stress injury classified as Fredericson grade 2 or 3 are randomly allocated to two groups. The intervention group receives Functional Magnetic Stimulation in addition to a structured four-week physiotherapy rehabilitation program, while the control group receives the same rehabilitation program without FMS. The rehabilitation program is based on symptom-guided activity modification, progressive lower-limb loading, strengthening, mobility exercises, neuromuscular control, and gradual return to impact-based activity. FMS is applied twice weekly for four weeks, for a total of eight 30-minute sessions, over the symptomatic tibial region. Assessments are performed at baseline, at the end of the four-week intervention period, and at 16-week follow-up. Outcomes include activity-related tibial pain assessed with the Numerical Pain Rating Scale, lower-limb functional ability assessed with the Greek version of the Lower Extremity Functional Scale, MRI-derived bone marrow edema extent, and Fredericson MRI grade. Continuous outcomes are analyzed using repeated-measures mixed analysis of variance, while Fredericson grade is analyzed as an ordinal repeated-measures outcome.
Expected Results: It is expected that athletes receiving Functional Magnetic Stimulation in addition to standardized physiotherapy rehabilitation will demonstrate greater reductions in activity-related tibial pain, greater improvements in lower-limb functional ability, and more favorable MRI-derived recovery compared with athletes receiving rehabilitation alone. The findings are expected to clarify whether FMS may serve as a useful adjunctive modality within a structured rehabilitation approach for athletes with tibial bone stress injury.
- Conditions
- Bone Marrow Edema
- Being tested
- Standardized physiotherapy rehabilitation with FMS, Standardized Physiotherapy without FMS
- Keywords
- Functional Magnetic Stimulation, Physiotherapy, Rehabilitation, Tibial Bone Stress Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized physiotherapy rehabilitation with FMSOther
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.
Standardized Physiotherapy without FMSOther
Participants in this group will follow the same standardized physiotherapy protocol as the first group, without the application of FMS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standardized Physiotherapy without FMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Description: Lower-limb function is evaluated using the Greek version of the Lower Extremity Functional Scale. This patient-reported measure includes 20 items related to daily and sport-related activities involving the lower limb. Each item is scored from 0 to 4, and the total score ranges from 0 to 80. Lower scores indicate greater functional limitation, whereas higher scores reflect better lower-limb functional ability.
Measured: baseline, week 4, week 16
Change in MRI-derived bone marrow edema extent
Bone marrow edema is assessed using magnetic resonance imaging of the affected tibia. The extent of edema is measured on fluid-sensitive MRI sequences as the maximum visible longitudinal length of intramedullary edema. The measurement is recorded in centimeters, with lower values indicating a smaller extent of bone marrow edema.
Measured: baseline, week 4, week 16
Change in Fredericson MRI grade
Tibial bone stress injury severity is evaluated using the Fredericson MRI grading system. This classification ranges from grade 0 to grade 4, with lower grades indicating less severe MRI findings and grade 4 indicating the presence of a fracture line. Changes in Fredericson grade are assessed over time to monitor MRI-defined recovery.
Measured: baseline, week 4, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
- Investigators
- Paris Iakovidis, PhD, Study chair, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234084
- Sponsor's protocol ID
- EC-15/2025
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07234084
- Acronym / sponsor ID
- EC-15/2025
- Conditions
- Bone Marrow Edema
- Keywords
- Functional Magnetic Stimulation, Physiotherapy, Rehabilitation, Tibial Bone Stress Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Tibial bone stress injury is a clinically relevant overuse condition in athletes and is commonly associated with bone marrow edema on magnetic resonance imaging. It typically presents with localized tibial pain during weight-bearing or sport-related loading and may interfere with training participation and return to activity. MRI is used to confirm the diagnosis, determine injury severity, and monitor structural recovery. Fredericson grades 2 and 3 represent tibial bone stress injuries with bone marrow edema but without a visible fracture line, and are usually treated conservatively through activity modification, graded loading, therapeutic exercise, and progressive rehabilitation. Functional Magnetic Stimulation (FMS) is a non-invasive electromagnetic intervention that can induce deep neuromuscular activation and may contribute to pain modulation, improved load tolerance, and local tissue responses. However, its role as an adjunctive intervention in athletes with MRI-confirmed tibial bone stress injury remains insufficiently investigated.
Aim: The aim of this randomized controlled clinical trial is to evaluate whether adding Functional Magnetic Stimulation to a standardized physiotherapy rehabilitation program provides additional benefits in athletes with MRI-confirmed tibial bone stress injury associated with bone marrow edema. The study examines whether the combined intervention leads to greater improvement in activity-related pain, lower-limb functional ability, and MRI-derived indicators of recovery compared with standardized rehabilitation alone.
Method: Forty athletes with MRI-confirmed tibial bone stress injury classified as Fredericson grade 2 or 3 are randomly allocated to two groups. The intervention group receives Functional Magnetic Stimulation in addition to a structured four-week physiotherapy rehabilitation program, while the control group receives the same rehabilitation program without FMS. The rehabilitation program is based on symptom-guided activity modification, progressive lower-limb loading, strengthening, mobility exercises, neuromuscular control, and gradual return to impact-based activity. FMS is applied twice weekly for four weeks, for a total of eight 30-minute sessions, over the symptomatic tibial region. Assessments are performed at baseline, at the end of the four-week intervention period, and at 16-week follow-up. Outcomes include activity-related tibial pain assessed with the Numerical Pain Rating Scale, lower-limb functional ability assessed with the Greek version of the Lower Extremity Functional Scale, MRI-derived bone marrow edema extent, and Fredericson MRI grade. Continuous outcomes are analyzed using repeated-measures mixed analysis of variance, while Fredericson grade is analyzed as an ordinal repeated-measures outcome.
Expected Results: It is expected that athletes receiving Functional Magnetic Stimulation in addition to standardized physiotherapy rehabilitation will demonstrate greater reductions in activity-related tibial pain, greater improvements in lower-limb functional ability, and more favorable MRI-derived recovery compared with athletes receiving rehabilitation alone. The findings are expected to clarify whether FMS may serve as a useful adjunctive modality within a structured rehabilitation approach for athletes with tibial bone stress injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Functional Magnetic Stimulation plus standardized physiotherapy rehabilitation | Experimental | Other: Standardized physiotherapy rehabilitation with FMSArm Description: Participants receive 12 physiotherapy rehabilitation sessions over four weeks plus eight 30-minute FMS sessions applied over the symptomatic tibial region. |
| Physiotherapy rehabilitation alone | Active comparator | Other: Standardized Physiotherapy without FMSParticipants in this group complete 12 supervised physiotherapy rehabilitation sessions over a four-week period and do not receive Functional Magnetic Stimulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized physiotherapy rehabilitation with FMSParticipants 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. | Other | Functional Magnetic Stimulation plus standardized physiotherapy rehabilitation |
| Standardized Physiotherapy without FMSParticipants in this group will follow the same standardized physiotherapy protocol as the first group, without the application of FMS | Other | Physiotherapy rehabilitation alone |
Primary outcome
Change in tibial pain during a standardized walking task
Time frame: baseline, week 4, week 16
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.
3 secondary outcomes
Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)
Time frame: baseline, week 4, week 16
Change in MRI-derived bone marrow edema extent
Time frame: baseline, week 4, week 16
Change in Fredericson MRI grade
Time frame: baseline, week 4, week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paris Iakovidis, PhD study chair
International Hellenic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized physiotherapy rehabilitation with FMS and Standardized Physiotherapy without FMS in people with Bone Marrow Edema, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tibial pain during a standardized walking task (time frame: baseline, week 4, week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.