The Effectiveness of Functional Magnetic Stimulation in the Physiotherapeutic Rehabilitation of Athletes With Bone Marrow Edema: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in tibial pain during a standardized walking task
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A masked assessor will conduct the measurements
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Change in tibial pain during a standardized walking task
时间窗: 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.
Changes in pain intensity with Numeric Rating Scale (NPRS)
时间窗: pre-treatment, week 4, Week 16
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.
Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)
时间窗: baseline, week 4, week 16
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).
Changes in bone marrow edema characteristics with Magnetic Resonance Imaging (MRI)
时间窗: baseline, week 4, week 16
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.
Changes in return-to-sport readiness with the Tegner Activity Scale and perceived sport pain
时间窗: baseline, week 4, week 16
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.
次要结局
- 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)
研究者
Dimitrios Lytras
Assistant Professor of Physiotherapy
International Hellenic University