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

Bispebjerg Hospital

Status: Completed

Conditions: Muscle Strain

Treatments: Procedure: Chronic Control; Procedure: Acute Early onset of rehabilitation; Procedure: Acute Delayed onset of rehabilitation; Procedure: Chronic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02152098

MI-114

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 4 patient groups

Chronic Exercise

Experimental group

Description:

Chronic Exercise

Treatment:

Procedure: Chronic Exercise

Acute Early onset of rehabilitation

Experimental group

Description:

Acute Early onset of rehabilitation

Treatment:

Procedure: Acute Early onset of rehabilitation

Chronic control

Experimental group

Description:

Chronic control

Treatment:

Procedure: Chronic Control

Acute Delayed onset of rehabilitation

Experimental group

Description:

Acute Delayed onset of rehabilitation

Treatment:

Procedure: Acute Delayed onset of rehabilitation