Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
Thessaloniki, Sindos, 57400, Greece
NCT Number: NCT07234084
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Thessaloniki, Sindos, 57400, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants in this group will follow the same standardized physiotherapy protocol as the first group, without the application of FMS
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.
Time frame: baseline, week 4, week 16
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.
Time frame: baseline, week 4, week 16
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.
Time frame: baseline, week 4, week 16
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.
International Hellenic University
Other
The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial
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