Optimal Treatment of Acute Skeletal Muscle Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBispebjerg Hospital
About this trial
Acute muscle strain injuries occur both during sports, in leisure time activities and during manual occupation and represent a major clinical challenge and has societal economic costs. The recovery time is long and a substantial injury recurrence is observed. Despite current best evidence rehabilitation with early mechanical loading, a significant loss of muscle mass, fatty infiltration and formation of scar tissue is reported.
Animal models and human in vitro experiments suggest that inflammation is vital in the early period after an injury, however an inhibition of inflammatory processes is beneficial for healing.
We investigate here whether a pharmacological inhibition of inflammatory pathways in the 2nd week following a muscle strain injury will provide a better clinical outcome and an advantageous cellular profile than rehabilitative training alone would.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sports-active individuals with an acute muscle train injury in either the hamstrings or calf muscle caused by an explosive movement (during sprinting, jumping etc)
Age older than 18 years
Disqualifiers
Lack of hypoechoic/ hyperechoic area on ultrasound
Diabetes type I and II
Connective tissue disorders, rheumatism or any other chronic disease affecting the musculoskeletal system
Anticoagulant medication
Trial design
Design model
Parallel
Treatments tested in this trial
Naproxen 500 Mg
DrugAttenuating the sub-acute inflammatory processes to monitor potential beneficial tissue healing following a muscle strain injury
Rehabilitation
Procedure/SurgeryRehabilitation after muscle strain injury
Placebo
DrugSub-acute inflammatory processes not attenuated. Group will be treated as control to monitor tissue healing following a muscle strain injury without pharmacological intervention.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Anti-inflammatory medicineExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Effect of anti-inflammatory medicine on cellular profile in skeletal muscle
Single-nuclei RNA sequencing (seq) of muscle tissue after a strain injury. Single nuclei RNA seq will be performed on biopsies obtained in week 1 after the strain injury. The cellular profile will be compared to the contralateral healthy muscle. Another biopsy, in both the injured and contralateral healthy muscle will be taken in week 3 post injury to investigate the effect of one week of Naproxen treatment versus inert placebo pills on the cellular profile measured with single nuclei RNA seq.
Time frame
12 monthsSecondary outcomes
1
Functional outcome performance
Return-to-Sport. The time from onset of injury until the participants full and pain-free return to sport will be recorded.
Time frame
Up to 12 months2
Functional outcome re-injury rate
The number of re-injuries, participants sustain within 12 months after the initial strain injury will be recorded.
Time frame
12 months3
Functional outcome Patient Related Outcome Measures (PROM)
Participants will be asked to fill in a strain injury specific questionnaire as a "Patient related outcome measures ("PROM"). The questionnaire has 5 sub-categories including pain, symptoms, soreness, function during daily activities and sports and quality of life.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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