Muscle StrainNCT02152098
Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
A study testing Acute Early onset of rehabilitation, Acute Delayed onset of rehabilitation and Chronic Exercise in people with Muscle Strain, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Strain
- What is being tested?
- Acute Early onset of rehabilitation, Acute Delayed onset of rehabilitation and Chronic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute muscle strain injury
- Chronic muscle strain injury
- Age above 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, Building 8
Copenhagen, 2400
About this study
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.
- Conditions
- Muscle Strain
- Being tested
- Acute Early onset of rehabilitation, Acute Delayed onset of rehabilitation, Chronic Exercise, Chronic Control
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Early onset of rehabilitationProcedure or surgery
Early onset of rehabilitation
Acute Delayed onset of rehabilitationProcedure or surgery
Delayed onset of rehabilitation
Chronic ExerciseProcedure or surgery
Exercise
Chronic ControlProcedure or surgery
Control
| Study group | Role | What they receive |
|---|---|---|
| Chronic Exercise | Experimental | Chronic Exercise Receives: Procedure: Chronic Exercise |
| Acute Early onset of rehabilitation | Experimental | Acute Early onset of rehabilitation Receives: Procedure: Acute Early onset of rehabilitation |
| Chronic control | Experimental | Chronic control Receives: Procedure: Chronic Control |
| Acute Delayed onset of rehabilitation | Experimental | Acute Delayed onset of rehabilitation Receives: Procedure: Acute Delayed onset of rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to full physical activity
First time the subject is fully fit to take part in all types of physical activity post injury;
Measured: Baseline; Up to 30 weeks (estimated time frame maximum)
Secondary outcomes (6)
Magnetic resonance images
Size of injured tissue; Size and location of hematoma; Measurement of muscle perfusion (indication of metabolic activity)
Measured: Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Size and location of injury
Measured: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Volume of hematoma
Measured: Baseline, 1 week, 2 weeks
Strength measurements
Strength tests of injured muscle group compared to healthy muscle group on contralateral leg
Measured: Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
Structural changes of tissue
Evaluation of tissue samples from injured muscle before and after rehabilitation program
Measured: Baseline, 12 weeks
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
Measured: Baseline, 3 -14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Monika Lucia Bayer, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152098
- Sponsor's protocol ID
- MI-114
- Status last verified
- Jul 2017
- First submitted
- 23 May 2014
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34264782
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Strain Injuries and the Connective Tissue: Characterization, Recovery and Optimal Treatment
- ClinicalTrials.gov ID
- NCT02152098
- Acronym / sponsor ID
- MI-114
- Conditions
- Muscle Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic Exercise | Experimental | Procedure: Chronic ExerciseChronic Exercise |
| Acute Early onset of rehabilitation | Experimental | Procedure: Acute Early onset of rehabilitationAcute Early onset of rehabilitation |
| Chronic control | Experimental | Procedure: Chronic ControlChronic control |
| Acute Delayed onset of rehabilitation | Experimental | Procedure: Acute Delayed onset of rehabilitationAcute Delayed onset of rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute muscle strain injury
- Chronic muscle strain injury
- Age above 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Early onset of rehabilitationEarly onset of rehabilitation | Procedure or surgery | Acute Early onset of rehabilitation |
| Acute Delayed onset of rehabilitationDelayed onset of rehabilitation | Procedure or surgery | Acute Delayed onset of rehabilitation |
| Chronic ExerciseExercise | Procedure or surgery | Chronic Exercise |
| Chronic ControlControl | Procedure or surgery | Chronic control |
Primary outcome
Return to full physical activity
Time frame: Baseline; Up to 30 weeks (estimated time frame maximum)
First time the subject is fully fit to take part in all types of physical activity post injury;
6 secondary outcomes
Magnetic resonance images
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Time frame: Baseline, 7-14 days, 4 weeks, 6 weeks, 12 weeks, 6 months
Ultrasound images
Time frame: Baseline, 1 week, 2 weeks
Strength measurements
Time frame: Baseline, 4 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months
Structural changes of tissue
Time frame: Baseline, 12 weeks
Aspiration and characterization of inter-/ intramuscular fluid in the injured muscle
Time frame: Baseline, 3 -14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Derived from this study: PubMed 34264782Bayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Early onset of rehabilitation, Acute Delayed onset of rehabilitation and Chronic Exercise in people with Muscle Strain, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to full physical activity (time frame: Baseline; Up to 30 weeks (estimated time frame maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.