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Completed

NCT Number: NCT02152098

Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment

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.

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Key information

Conditions

Muscle Strain Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Early onset of rehabilitation

Procedure

Early onset of rehabilitation

Acute Delayed onset of rehabilitation

Procedure

Delayed onset of rehabilitation

Chronic Exercise

Procedure

Exercise

Chronic Control

Procedure

Control

Primary outcomes

  1. Return to full physical activity

    Time frame: 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 outcomes

  1. Magnetic resonance images

    Time frame: 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)

  2. Ultrasound images

    Time frame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months

    Size and location of injury

  3. Ultrasound images

    Time frame: Baseline, 1 week, 2 weeks

    Volume of hematoma

  4. Strength measurements

    Time frame: 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

  5. Structural changes of tissue

    Time frame: Baseline, 12 weeks

    Evaluation of tissue samples from injured muscle before and after rehabilitation program

  6. Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle

    Time frame: 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

Other outcomes

  1. Pain score on the Visual Analog Scale

    Time frame: 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.

  2. Injury screening questionnaire

    Time frame: 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.

  3. Rehabilitation registration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 2, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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