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

Muscle Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152098
• Other study ID #: MI-114
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: July 25, 2017
• Start date: April 2014
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Strain
• Sprains and Strains

Intervention

Procedure:
• Acute Early onset of rehabilitation
Early onset of rehabilitation
• Acute Delayed onset of rehabilitation
Delayed onset of rehabilitation
• Chronic Exercise
Exercise
• Chronic Control
Control

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score on the Visual Analog Scale	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
Other	Injury screening questionnaire	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
Other	Rehabilitation registration	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
Primary	Return to full physical activity	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	Magnetic resonance images	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
Secondary	Ultrasound images	Size and location of injury	Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
Secondary	Ultrasound images	Volume of hematoma	Baseline, 1 week, 2 weeks
Secondary	Strength measurements	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
Secondary	Structural changes of tissue	Evaluation of tissue samples from injured muscle before and after rehabilitation program	Baseline, 12 weeks
Secondary	Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle	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