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

Primary Purpose

Muscle Strain

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Acute Early onset of rehabilitation

Acute Delayed onset of rehabilitation

Chronic Exercise

Chronic Control

About this trial

This is an interventional treatment trial for Muscle Strain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Chronic Exercise

Acute Early onset of rehabilitation

Chronic control

Acute Delayed onset of rehabilitation

Arm Description

Chronic Exercise

Acute Early onset of rehabilitation

Chronic control

Acute Delayed onset of rehabilitation

Outcomes

Primary Outcome Measures

Return to full physical activity

First time the subject is fully fit to take part in all types of physical activity post injury;

Secondary Outcome Measures

Magnetic resonance images

Size of injured tissue; Size and location of hematoma; Measurement of muscle perfusion (indication of metabolic activity)

Ultrasound images

Size and location of injury

Ultrasound images

Volume of hematoma

Strength measurements

Strength tests of injured muscle group compared to healthy muscle group on contralateral leg

Structural changes of tissue

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

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

Full Information

NCT ID

NCT02152098

First Posted

May 23, 2014

Last Updated

July 25, 2017

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT02152098

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

4. Oversight

Data Monitoring Committee

5. Study Description

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: Humoral growth factors and pro-inflammatory macrophages released into the injured area post strain injury stimulate formation of connective tissue in vitro. 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. Scar tissue following a muscle strain injury is characterized by disorganized structure of connective tissue. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Strain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic Exercise

Arm Type

Experimental

Arm Description

Chronic Exercise

Arm Title

Acute Early onset of rehabilitation

Arm Type

Experimental

Arm Description

Acute Early onset of rehabilitation

Arm Title

Chronic control

Arm Type

Experimental

Arm Description

Chronic control

Arm Title

Acute Delayed onset of rehabilitation

Arm Type

Experimental

Arm Description

Acute Delayed onset of rehabilitation

Intervention Type

Procedure

Intervention Name(s)

Acute Early onset of rehabilitation

Intervention Description

Early onset of rehabilitation

Intervention Type

Procedure

Intervention Name(s)

Acute Delayed onset of rehabilitation

Intervention Description

Delayed onset of rehabilitation

Intervention Type

Procedure

Intervention Name(s)

Chronic Exercise

Intervention Description

Exercise

Intervention Type

Procedure

Intervention Name(s)

Chronic Control

Intervention Description

Control

Primary Outcome Measure Information:

Title

Return to full physical activity

Description

First time the subject is fully fit to take part in all types of physical activity post injury;

Time Frame

Baseline; Up to 30 weeks (estimated time frame maximum)

Secondary Outcome Measure Information:

Title

Magnetic resonance images

Description

Size of injured tissue; Size and location of hematoma; Measurement of muscle perfusion (indication of metabolic activity)

Time Frame

Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months

Title

Ultrasound images

Description

Size and location of injury

Time Frame

Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months

Title

Ultrasound images

Description

Volume of hematoma

Time Frame

Baseline, 1 week, 2 weeks

Title

Strength measurements

Description

Strength tests of injured muscle group compared to healthy muscle group on contralateral leg

Time Frame

Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months

Title

Structural changes of tissue

Description

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

Time Frame

Baseline, 12 weeks

Title

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

Description

The aspirated fluid (hematoma/exudate) will be analyzed for released humoral factors, cell types present and its effect on human fibroblast proliferation

Time Frame

Baseline, 3 -14 days

Other Pre-specified Outcome Measures:

Title

Pain score on the Visual Analog Scale

Description

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.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks

Title

Injury screening questionnaire

Description

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.

Time Frame

Baseline, 1,2,3,4,5,6,7,8,9,10,11,12 weeks, 6 and 12 months

Title

Rehabilitation registration

Description

Each subject is asked to keep a regular training diary of his/ her rehabilitation progress.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

34264782

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.

Results Reference

derived

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

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