Clinical trial NCT02152098: Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
Official title: Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strain
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2014-06-02
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Return to full physical activity
timeFrame: Baseline; Up to 30 weeks (estimated time frame maximum)
Secondary outcomes:
measure: Magnetic resonance images
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
measure: Ultrasound images
timeFrame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
measure: Ultrasound images
timeFrame: Baseline, 1 week, 2 weeks
measure: Strength measurements
timeFrame: Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
measure: Structural changes of tissue
timeFrame: Baseline, 12 weeks
measure: Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle
timeFrame: Baseline, 3 -14 days
Other outcomes:
measure: Pain score on the Visual Analog Scale
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
measure: Injury screening questionnaire
timeFrame: Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months
measure: Rehabilitation registration
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8
Study officials:
References:
citation: Bayer ML, Hoegberget-Kalisz M, Svensson RB, Hjortshoej MH, Olesen JL, Nybing JD, Boesen M, Magnusson SP, Kjaer M. Chronic Sequelae After Muscle Strain Injuries: Influence of Heavy Resistance Training on Functional and Structural Characteristics in a Randomized Controlled Trial. Am J Sports Med. 2021 Aug;49(10):2783-2794. doi: 10.1177/03635465211026623. Epub 2021 Jul 15.