Muscle Strain
Conditions
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.
Interventions
PROCEDUREAcute Early onset of rehabilitation
Early onset of rehabilitation
PROCEDUREAcute Delayed onset of rehabilitation
Delayed onset of rehabilitation
PROCEDUREChronic Exercise
Exercise
PROCEDUREChronic Control
Control
Sponsors
University of Copenhagen
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound images | Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months | Size and location of injury |
| 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 |
| Structural changes of tissue | Baseline, 12 weeks | Evaluation of tissue samples from injured muscle before and after rehabilitation program |
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation registration | Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks | Each subject is asked to keep a regular training diary of his/ her rehabilitation progress. |
| Injury screening questionnaire | Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months | 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. |
| Pain score on the Visual Analog Scale | Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks | 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. |
Countries
Denmark
Outcome results
None listed