NCT02152098

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:

  1. 1.Humoral growth factors and pro-inflammatory macrophages released into the injured area post strain injury stimulate formation of connective tissue in vitro.
  2. 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. 3.Scar tissue following a muscle strain injury is characterized by disorganized structure of connective tissue.
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

May 23, 2014

Last Update Submit

July 25, 2017

Conditions

Muscle Strain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Magnetic resonance images

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

  • Ultrasound images

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

  • Ultrasound images

    Baseline, 1 week, 2 weeks

  • Strength measurements

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

  • Structural changes of tissue

    Baseline, 12 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Pain score on the Visual Analog Scale

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

  • Injury screening questionnaire

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

  • Rehabilitation registration

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

Study Arms (4)

Chronic Exercise

EXPERIMENTAL

Chronic Exercise

Procedure: Chronic Exercise

Acute Early onset of rehabilitation

EXPERIMENTAL

Acute Early onset of rehabilitation

Procedure: Acute Early onset of rehabilitation

Chronic control

EXPERIMENTAL

Chronic control

Procedure: Chronic Control

Acute Delayed onset of rehabilitation

EXPERIMENTAL

Acute Delayed onset of rehabilitation

Procedure: Acute Delayed onset of rehabilitation

Interventions

Acute Early onset of rehabilitationPROCEDURE

Early onset of rehabilitation

Acute Early onset of rehabilitation
Acute Delayed onset of rehabilitationPROCEDURE

Delayed onset of rehabilitation

Acute Delayed onset of rehabilitation
Chronic ExercisePROCEDURE

Exercise

Chronic Exercise
Chronic ControlPROCEDURE

Control

Chronic control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute muscle strain injury
  • Chronic muscle strain injury
  • Age above 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34264782DERIVED

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 2, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

DK(1)