面向运动员骨髓水肿的功能性磁刺激(FMS)
功能性磁刺激在运动员骨髓水肿物理治疗康复中的有效性:一项随机对照试验
研究概览
地位
条件
详细说明
背景:骨髓水肿是运动员中一种可逆的应力相关性骨损伤,负重时会引起局部疼痛,并通过诊断与监测金标准磁共振成像(MRI)确认。 Fredericson分级的2级和3级代表具有临床意义的无骨折线水肿,通过包括运动疗法、手法技术和渐进负重在内的物理治疗进行保守管理。 功能性磁刺激(FMS)是一种非侵入性方法,可诱导深层神经肌肉激活并改善血液循环。 尽管在肌肉骨骼康复中应用日益广泛,但其对骨髓水肿恢复的效果尚未在对照临床环境中进行测试。
目的:本随机对照临床试验旨在评估在结构化物理治疗康复方案基础上加用功能性磁刺激,对经MRI确诊的下肢骨髓水肿运动员的疗效。 主要目的是确定与单纯物理治疗相比,联合治疗方案是否能带来更显著的临床改善、更优越的功能恢复以及更快的影像学水肿消退。
方法:40名经MRI判定为Fredericson 2级或3级的下肢骨髓水肿运动员将被随机分为两组。 干预组将进行为期四周的物理治疗计划,结合治疗性运动、手法治疗和减负技术,并每周两次施加功能性磁刺激。 对照组将接受相同但不含FMS的物理治疗。 评估将在基线期、第二周、第四周和第十六周进行,包括疼痛程度(数字评定量表0-10分)、功能活动能力(下肢功能量表希腊版)和重返运动准备度(Tegner量表)。 在基线期、第4周和第16周进行的MRI将评估Fredericson分级、水肿强度和水肿范围。 所有参数均预先确定为主要结局指标。 数据将采用混合模型方差分析进行重复测量分析,显著性水平设定为p<0.05。
预期结果:预计接受功能性磁刺激联合物理治疗的运动员,与单纯物理治疗组相比,将表现出更显著的疼痛减轻、更佳的下肢功能改善、更快的MRI证实的骨髓水肿消退以及更早的重返运动准备度。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Sindos
-
Thessaloniki、Sindos、希腊、57400
- Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
纳入标准:
- 年龄18-45岁的运动员,过去6个月内每周定期参加体育训练≥3次。
- 经MRI确诊下肢骨髓水肿(BME),Fredericson分级为2级或3级。
- 疼痛或症状在最近6周内出现。
- 负重活动时数字评分量表疼痛强度≥4/10。
- 能够配合完成4周干预及16周随访评估。
- 参与前签署书面知情同意书。
排除标准:
- Fredericson分级4级或MRI显示骨折线证据
- 继发于感染、肿瘤或全身性炎症疾病的骨髓水肿
- 12周内受累肢体有近期骨折、手术或关节内注射史
- 入组前8周内曾接受功能性磁刺激或体外冲击波治疗
- 存在金属植入物、心脏起搏器或其他磁刺激禁忌证
妊娠或哺乳期
使用全身性皮质类固醇或影响骨代谢的药物
任何可能影响安全参与的神经、代谢或心血管疾病
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Functional Magnetic Stimulation plus standardized physiotherapy rehabilitation
Arm Description: Participants receive 12 physiotherapy rehabilitation sessions over four weeks plus eight 30-minute FMS sessions applied over the symptomatic tibial region.
|
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.
|
|
有源比较器:Physiotherapy rehabilitation alone
Participants in this group complete 12 supervised physiotherapy rehabilitation sessions over a four-week period and do not receive Functional Magnetic Stimulation.
|
Participants in this group will follow the same standardized physiotherapy protocol as the first group, without the application of FMS
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in tibial pain during a standardized walking task
大体时间: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.
|
baseline, week 4, week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in lower-limb functional ability with the Greek Version of the Lower Extremity Functional Scale (LEFS-GR)
大体时间: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.
|
baseline, week 4, week 16
|
|
Change in MRI-derived bone marrow edema extent
大体时间: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.
|
baseline, week 4, week 16
|
|
Change in Fredericson MRI grade
大体时间: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.
|
baseline, week 4, week 16
|
合作者和调查者
调查人员
- 学习椅:Paris Iakovidis, PhD、International Hellenic University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- EC-15/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.