Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Return to full physical activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute muscle strain injury
- •Chronic muscle strain injury
- •Age above 18 years
排除标准
- •Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within three months prior to the injury
- •Connective tissue and/or rheumatic diseases
- •Any observed organ dysfunctions
研究组 & 干预措施
Chronic Exercise
Chronic Exercise
干预措施: Chronic Exercise (Procedure)
Acute Early onset of rehabilitation
Acute Early onset of rehabilitation
干预措施: Acute Early onset of rehabilitation (Procedure)
Chronic control
Chronic control
干预措施: Chronic Control (Procedure)
Acute Delayed onset of rehabilitation
Acute Delayed onset of rehabilitation
干预措施: Acute Delayed onset of rehabilitation (Procedure)
结局指标
主要结局
Return to full physical activity
时间窗: Baseline; Up to 30 weeks (estimated time frame maximum)
First time the subject is fully fit to take part in all types of physical activity post injury;
次要结局
- Ultrasound images(Baseline, 1 week, 2 weeks)
- Structural changes of tissue(Baseline, 12 weeks)
- Magnetic resonance images(Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months)
- Strength measurements(Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months)
- Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle(Baseline, 3 -14 days)
研究者
Monika Lucia Bayer
PhD
Bispebjerg Hospital