Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
2017年7月25日 更新者：Monika Lucia Bayer、Bispebjerg Hospital
Firstly, the investigators aim to study the biochemical, structural and functional changes associated with acute muscle strain injury in the acute phase and during rehabilitation in vivo. Specific factors present after the injury and their effects on connective tissue cells will be examined in vitro.
Secondly, the investigators will investigate individuals with chronic pain, scar tissue and inferior function after a previous muscle strain injury and test a specific rehabilitation program to alleviate pain and disabilities associated with the preceding muscle injury. The investigators have the following hypotheses:
- Humoral growth factors and pro-inflammatory macrophages released into the injured area post strain injury stimulate formation of connective tissue in vitro.
- Early onset of rehabilitation will be superior to a delayed start of rehabilitation for the healing process, in regards to structural improvement of tissue and better clinical function.
- Scar tissue following a muscle strain injury is characterized by disorganized structure of connective tissue.
- Mechanical loading in the form of heavy eccentric muscle activity for 12 weeks will lead to a local re-modeling of scar tissue, and result in improved function and reduced symptoms in patients with chronic pain and impaired function after a previous muscle injury.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
85
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Copenhagen、丹麦、2400
- Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Acute muscle strain injury
- Chronic muscle strain injury
- Age above 18 years
Exclusion Criteria:
- Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within three months prior to the injury
- Smoking
- Diabetes
- Connective tissue and/or rheumatic diseases
- Any observed organ dysfunctions
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Chronic Exercise
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Exercise
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实验性的：Acute Early onset of rehabilitation
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Early onset of rehabilitation
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实验性的：Chronic control
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Control
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实验性的：Acute Delayed onset of rehabilitation
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Delayed onset of rehabilitation
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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 |
|---|---|---|
|
Return to full physical activity
大体时间：Baseline; Up to 30 weeks (estimated time frame maximum)
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First time the subject is fully fit to take part in all types of physical activity post injury;
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Baseline; Up to 30 weeks (estimated time frame maximum)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Magnetic resonance images
大体时间：Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
|
Size of injured tissue; Size and location of hematoma; Measurement of muscle perfusion (indication of metabolic activity)
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Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
|
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Ultrasound images
大体时间：Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
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Size and location of injury
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Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
|
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Ultrasound images
大体时间：Baseline, 1 week, 2 weeks
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Volume of hematoma
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Baseline, 1 week, 2 weeks
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Strength measurements
大体时间：Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
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Strength tests of injured muscle group compared to healthy muscle group on contralateral leg
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Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
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Structural changes of tissue
大体时间：Baseline, 12 weeks
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Evaluation of tissue samples from injured muscle before and after rehabilitation program
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Baseline, 12 weeks
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Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle
大体时间：Baseline, 3 -14 days
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The aspirated fluid (hematoma/exudate) will be analyzed for released humoral factors, cell types present and its effect on human fibroblast proliferation
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Baseline, 3 -14 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain score on the Visual Analog Scale
大体时间：Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
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Each subject is asked to rate his/ her pain level on the Visual Analog Scale during each rehabilitation session at a pre-defined time points during the work-out.
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Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
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Injury screening questionnaire
大体时间：Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months
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Each subject is asked to fill out a questionnaire to record the impact of the injury on his/her physical activity and activities of daily living.
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Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months
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Rehabilitation registration
大体时间：Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
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Each subject is asked to keep a regular training diary of his/ her rehabilitation progress.
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Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2014年5月23日
首先提交符合 QC 标准的
2014年5月30日
首次发布 (估计)
2014年6月2日
研究记录更新
最后更新发布 (实际的)
2017年7月26日
上次提交的符合 QC 标准的更新
2017年7月25日
最后验证
2017年7月1日
更多信息
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.