Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
- Conditions
- Muscle Strain
- Interventions
- Procedure: Acute Early onset of rehabilitationProcedure: Chronic ControlProcedure: Acute Delayed onset of rehabilitationProcedure: Chronic Exercise
- Registration Number
- NCT02152098
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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:
1. Humoral growth factors and pro-inflammatory macrophages released into the injured area post strain injury stimulate formation of connective tissue in vitro.
2. 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.
3. Scar tissue following a muscle strain injury is characterized by disorganized structure of connective tissue.
4. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Acute muscle strain injury
- Chronic muscle strain injury
- Age above 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute Early onset of rehabilitation Acute Early onset of rehabilitation Acute Early onset of rehabilitation Chronic control Chronic Control Chronic control Acute Delayed onset of rehabilitation Acute Delayed onset of rehabilitation Acute Delayed onset of rehabilitation Chronic Exercise Chronic Exercise Chronic Exercise
- Primary Outcome Measures
Name Time Method Return to full physical activity 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;
- Secondary Outcome Measures
Name Time Method Ultrasound images Baseline, 1 week, 2 weeks Volume of hematoma
Structural changes of tissue Baseline, 12 weeks Evaluation of tissue samples from injured muscle before and after rehabilitation program
Magnetic resonance images 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)
Strength measurements Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months Strength tests of injured muscle group compared to healthy muscle group on contralateral leg
Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle Baseline, 3 -14 days The aspirated fluid (hematoma/exudate) will be analyzed for released humoral factors, cell types present and its effect on human fibroblast proliferation
Trial Locations
- Locations (1)
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8
🇩🇰Copenhagen, Denmark