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Trial record 26 of 351 for:    sprains and strains

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

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ClinicalTrials.gov Identifier: NCT02152098
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Monika Lucia Bayer, Bispebjerg Hospital

Tracking Information
First Submitted Date  ICMJE May 23, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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;
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02152098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
  • 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)
  • Ultrasound images [ Time Frame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months ]
    Size and location of injury
  • Ultrasound images [ Time Frame: Baseline, 1 week, 2 weeks ]
    Volume of hematoma
  • 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
  • Structural changes of tissue [ Time Frame: 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 [ 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2014)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
Official Title  ICMJE Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Muscle Strain
Intervention  ICMJE
  • Procedure: Acute Early onset of rehabilitation
    Early onset of rehabilitation
  • Procedure: Acute Delayed onset of rehabilitation
    Delayed onset of rehabilitation
  • Procedure: Chronic Exercise
    Exercise
  • Procedure: Chronic Control
    Control
Study Arms  ICMJE
  • Experimental: Chronic Exercise
    Chronic Exercise
    Intervention: Procedure: Chronic Exercise
  • Experimental: Acute Early onset of rehabilitation
    Acute Early onset of rehabilitation
    Intervention: Procedure: Acute Early onset of rehabilitation
  • Experimental: Chronic control
    Chronic control
    Intervention: Procedure: Chronic Control
  • Experimental: Acute Delayed onset of rehabilitation
    Acute Delayed onset of rehabilitation
    Intervention: Procedure: Acute Delayed onset of rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
85
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)
100
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152098
Other Study ID Numbers  ICMJE MI-114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monika Lucia Bayer, Bispebjerg Hospital
Study Sponsor  ICMJE Bispebjerg Hospital
Collaborators  ICMJE University of Copenhagen
Investigators  ICMJE Not Provided
PRS Account Bispebjerg Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP