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

July 25, 2017 updated by: Monika Lucia Bayer, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Exercise
Procedure: Chronic Exercise
Exercise
Experimental: Acute Early onset of rehabilitation
Procedure: Acute Early onset of rehabilitation
Early onset of rehabilitation
Experimental: Chronic control
Procedure: Chronic Control
Control
Experimental: Acute Delayed onset of rehabilitation
Procedure: Acute Delayed onset of rehabilitation
Delayed onset of rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
Baseline; Up to 30 weeks (estimated time frame maximum)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Time Frame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
Size and location of injury
Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Time Frame: Baseline, 1 week, 2 weeks
Volume of hematoma
Baseline, 1 week, 2 weeks
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
Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
Structural changes of tissue
Time Frame: Baseline, 12 weeks
Evaluation of tissue samples from injured muscle before and after rehabilitation program
Baseline, 12 weeks
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
Baseline, 3 -14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks
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.
Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months
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.
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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