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

NCT ID: NCT02152098

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Muscle Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Exercise

Chronic Exercise

Group Type EXPERIMENTAL

Chronic Exercise

Intervention Type PROCEDURE

Exercise

Acute Early onset of rehabilitation

Acute Early onset of rehabilitation

Group Type EXPERIMENTAL

Acute Early onset of rehabilitation

Intervention Type PROCEDURE

Early onset of rehabilitation

Chronic control

Chronic control

Group Type EXPERIMENTAL

Chronic Control

Intervention Type PROCEDURE

Control

Acute Delayed onset of rehabilitation

Acute Delayed onset of rehabilitation

Group Type EXPERIMENTAL

Acute Delayed onset of rehabilitation

Intervention Type PROCEDURE

Delayed onset of rehabilitation

Interventions

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Acute Early onset of rehabilitation

Early onset of rehabilitation

Intervention Type PROCEDURE

Acute Delayed onset of rehabilitation

Delayed onset of rehabilitation

Intervention Type PROCEDURE

Chronic Exercise

Exercise

Intervention Type PROCEDURE

Chronic Control

Control

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Monika Lucia Bayer

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34264782 (View on PubMed)

Other Identifiers

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MI-114

Identifier Type: -

Identifier Source: org_study_id

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