Muscle Strain, Multiple SitesNCT06274151
Optimal Treatment of Acute Skeletal Muscle Injury
A study testing Naproxen 500 Mg and Rehabilitation in people with Muscle Strain, Multiple Sites and Inflammation, run by Bispebjerg Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Strain, Multiple Sites, Inflammation
- What is being tested?
- Naproxen 500 Mg and Rehabilitation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Needle phobia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Simon E Jespersen, MD contact
About this study
Official title: Optimal Treatment of Inflammation Following Acute Skeletal Muscle Injury
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.
Read the detailed description
Injuries in skeletal muscle occur in sports, under recreational activities and during manual occupational work, and it represents both a significant clinical challenge and a burden for the individual in the form of long-term functional disability and pain, and for society causing a major economic cost (Ekstrand 2011). Traumatic muscle strain injuries occur most often in the hamstring and the calf region, are caused by high-force movements and most often result in a partial defect at the muscle-tendon (aponeurosis) interface (Tidball 1993, 2017). A major clinical challenge is that the recovery after a traumatic muscle strain injury is often long and in addition to this, substantial injury recurrence is observed. Several studies estimate that 80% of re-injuries occur at the site of the original injury (Wangensteen 2016).
It is known that early mechanical loading is important for shortening the period until pain-free return-to-sport (Bayer 2017). Whereas that study supports the role for mechanical loading in tissue repair and clinical recovery in the form of pain-free return to sports, early loading did not prevent muscle strength reduction and a significant loss of muscle mass in the injured muscle group, indicating that the recovery of the injured region is incomplete (Bayer 2018).
Experimental muscle injury precipitates an inflammatory response in the damaged tissue, which includes sequential infiltration of many cells and the release of inflammatory cytokines and growth factors (Chazaud 2016). Further, a study with human muscle cells and tissue after experimentally induced muscle injury found that a pro-inflammatory phase characterized by M1-macrophages was obligatory needed in the first 7 days after injury in order to initiate the healing process, manifested as proliferation capacity of the myogenic precursor cells (MPC) (Saclier 2013). It can be argued thus that a blockade of this proinflammatory phase would inhibit the healing process. In contrast, to advance the healing process after this initial pro-inflammatory phase, a switch to more anti-inflammatory activity - M2-macrophage activity - was needed in the later phase (7-14 days) to ensure differentiation of the MPC and thus a continued regeneration of tissue (Saclier2013). It is therefore possible that this anti-inflammatory stage is vital and that continued inflammation would cause an overall suboptimal healing response. Recently, a long-lasting inflammatory response after a muscle strain injury was reported. Based on analysis of injury exudates, very high levels of several pro-inflammatory factors were observed (Bayer 2019). Persistent presence of inflammation is linked to the development of fibrotic tissue changes in the long run (Wynn 2016) and importantly, fibrotic changes have been described following strain injuries (Bayer 2021, Silder 2008). Also, as prolonged elevated TNF-α (tumor necrosis factor-α) is known as an activator of the Nuclear Factor NF-κB pathway, this could cause stimulation of muscle atrophy related genes (Cohen 2015). It appears therefore clinically relevant to ensure that the pro-inflammatory phase following strain injuries is initially undisturbed, but the continuous pro-inflammatory phase is blunted to reduce the formation of fibrosis.
The aim of the present study is to test the hypothesis that an inhibition of inflammation, combined with the best standard training regimen in the later phase of recovery after injury (day 7-14) will provide a more optimal tissue recovery after injury than training alone will do.
The overall hypothesis is that administration of NSAID in the second week after an acute muscle strain injury in otherwise healthy humans, will be beneficial for tissue healing, characterized by an improved cellular composition allowing for less scar formation in the regeneration phase.
Participants will undergo a basic physical examination, including ultrasonographic scanning of the injured muscle site and fulfill questionnaire regarding previous injury history and present activities as well as symptoms.
Participants are then randomized to either placebo or NSAID treatment (Bonyl/ Naproxen 500 mg x 2 per day for 7 days) starting on day 7 and continued until day 14 post injury.
When participants are free of pain during movement including repeated explosive movements, the duration of the injury onset until full recovery is recorded (time to return to sports). Each participant will be followed by questionnaires for one year to record potential re-injuries.
Biopsies will be taken in week 1 post injury, before the pharmacological intervention, and in week 3 post injury, after the pharmacological intervention.
Biopsies will be analyzed by single nuclei RNA sequencing. Bioinformatics will be applied to investigate the distribution and number of cells in the injured muscle. Each biopsy will be compared to the control muscle (the same muscle as the injured one on the healthy, contralateral leg).
The biopsies will be obtained with a semi-automatic equipment that is routinely used to sample tendon tissue and tissue from chronic scar area in muscle (Bard Monopty) with a diameter of 1,6 mm a length of 10 mm.
- Conditions
- Muscle Strain, Multiple Sites, Inflammation
- Being tested
- Naproxen 500 Mg, Rehabilitation, Placebo
- Medical subject headings
- Sprains and Strains, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen 500 MgDrug
Also called Anti-inflammatory Agents, Non-steroidal
Attenuating the sub-acute inflammatory processes to monitor potential beneficial tissue healing following a muscle strain injury
RehabilitationProcedure or surgery
Also called Physical therapy to stimulate tissue healing
Rehabilitation after muscle strain injury
PlaceboDrug
Also called inert pills
Sub-acute inflammatory processes not attenuated. Group will be treated as control to monitor tissue healing following a muscle strain injury without pharmacological intervention.
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory medicine | Experimental | Week 2 after muscle strain injury Naproxen 500mg 2x daily Receives: Drug: Naproxen 500 Mg; Procedure: Rehabilitation |
| Placebo | Placebo comparator | Week 2 after muscle strain injury Placebo pill, no active compounds 2x daily Receives: Procedure: Rehabilitation; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: Up to 12 months
Functional outcome re-injury rate
The number of re-injuries, participants sustain within 12 months after the initial strain injury will be recorded.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Muscle Strain, Multiple SitesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Lucia Bayer, Bispebjerg Hospital
- Investigators
- Michael L Kjaer, DMSCi, Study director, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274151
- Sponsor's protocol ID
- H-22038917
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ekstrand J, Hagglund M, Walden M. Injury incidence and injury patterns in professional football: the UEFA injury study. Br J Sports Med. 2011 Jun;45(7):553-8. doi: 10.1136/bjsm.2009.060582. Epub 2009 Jun 23.
PubMed 19553225Wangensteen A, Tol JL, Witvrouw E, Van Linschoten R, Almusa E, Hamilton B, Bahr R. Hamstring Reinjuries Occur at the Same Location and Early After Return to Sport: A Descriptive Study of MRI-Confirmed Reinjuries. Am J Sports Med. 2016 Aug;44(8):2112-21. doi: 10.1177/0363546516646086. Epub 2016 May 16.
PubMed 27184543Chazaud B. Inflammation during skeletal muscle regeneration and tissue remodeling: application to exercise-induced muscle damage management. Immunol Cell Biol. 2016 Feb;94(2):140-5. doi: 10.1038/icb.2015.97. Epub 2015 Nov 3.
PubMed 26526620Saclier M, Yacoub-Youssef H, Mackey AL, Arnold L, Ardjoune H, Magnan M, Sailhan F, Chelly J, Pavlath GK, Mounier R, Kjaer M, Chazaud B. Differentially activated macrophages orchestrate myogenic precursor cell fate during human skeletal muscle regeneration. Stem Cells. 2013 Feb;31(2):384-96. doi: 10.1002/stem.1288.
PubMed 23169615Wynn TA, Vannella KM. Macrophages in Tissue Repair, Regeneration, and Fibrosis. Immunity. 2016 Mar 15;44(3):450-462. doi: 10.1016/j.immuni.2016.02.015.
PubMed 26982353Bayer 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 34264782Bayer ML, Magnusson SP, Kjaer M; Tendon Research Group Bispebjerg. Early versus Delayed Rehabilitation after Acute Muscle Injury. N Engl J Med. 2017 Sep 28;377(13):1300-1301. doi: 10.1056/NEJMc1708134. No abstract available.
PubMed 28953439Bayer ML, Hoegberget-Kalisz M, Jensen MH, Olesen JL, Svensson RB, Couppe C, Boesen M, Nybing JD, Kurt EY, Magnusson SP, Kjaer M. Role of tissue perfusion, muscle strength recovery, and pain in rehabilitation after acute muscle strain injury: A randomized controlled trial comparing early and delayed rehabilitation. Scand J Med Sci Sports. 2018 Dec;28(12):2579-2591. doi: 10.1111/sms.13269. Epub 2018 Aug 16.
PubMed 30043997Silder A, Sherry MA, Sanfilippo J, Tuite MJ, Hetzel SJ, Heiderscheit BC. Clinical and morphological changes following 2 rehabilitation programs for acute hamstring strain injuries: a randomized clinical trial. J Orthop Sports Phys Ther. 2013 May;43(5):284-99. doi: 10.2519/jospt.2013.4452. Epub 2013 Mar 13.
PubMed 23485730Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
PubMed 25549588Bayer ML, Bang L, Hoegberget-Kalisz M, Svensson RB, Olesen JL, Karlsson MM, Schjerling P, Hellsten Y, Hoier B, Magnusson SP, Kjaer M. Muscle-strain injury exudate favors acute tissue healing and prolonged connective tissue formation in humans. FASEB J. 2019 Sep;33(9):10369-10382. doi: 10.1096/fj.201900542R. Epub 2019 Jun 18.
PubMed 31211922
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment of Inflammation Following Acute Skeletal Muscle Injury
- ClinicalTrials.gov ID
- NCT06274151
- Acronym / sponsor ID
- H-22038917
- Conditions
- Muscle Strain, Multiple Sites, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Feb 2024 (actual)
- 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.
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.
Detailed description
Injuries in skeletal muscle occur in sports, under recreational activities and during manual occupational work, and it represents both a significant clinical challenge and a burden for the individual in the form of long-term functional disability and pain, and for society causing a major economic cost (Ekstrand 2011). Traumatic muscle strain injuries occur most often in the hamstring and the calf region, are caused by high-force movements and most often result in a partial defect at the muscle-tendon (aponeurosis) interface (Tidball 1993, 2017). A major clinical challenge is that the recovery after a traumatic muscle strain injury is often long and in addition to this, substantial injury recurrence is observed. Several studies estimate that 80% of re-injuries occur at the site of the original injury (Wangensteen 2016).
It is known that early mechanical loading is important for shortening the period until pain-free return-to-sport (Bayer 2017). Whereas that study supports the role for mechanical loading in tissue repair and clinical recovery in the form of pain-free return to sports, early loading did not prevent muscle strength reduction and a significant loss of muscle mass in the injured muscle group, indicating that the recovery of the injured region is incomplete (Bayer 2018).
Experimental muscle injury precipitates an inflammatory response in the damaged tissue, which includes sequential infiltration of many cells and the release of inflammatory cytokines and growth factors (Chazaud 2016). Further, a study with human muscle cells and tissue after experimentally induced muscle injury found that a pro-inflammatory phase characterized by M1-macrophages was obligatory needed in the first 7 days after injury in order to initiate the healing process, manifested as proliferation capacity of the myogenic precursor cells (MPC) (Saclier 2013). It can be argued thus that a blockade of this proinflammatory phase would inhibit the healing process. In contrast, to advance the healing process after this initial pro-inflammatory phase, a switch to more anti-inflammatory activity - M2-macrophage activity - was needed in the later phase (7-14 days) to ensure differentiation of the MPC and thus a continued regeneration of tissue (Saclier2013). It is therefore possible that this anti-inflammatory stage is vital and that continued inflammation would cause an overall suboptimal healing response. Recently, a long-lasting inflammatory response after a muscle strain injury was reported. Based on analysis of injury exudates, very high levels of several pro-inflammatory factors were observed (Bayer 2019). Persistent presence of inflammation is linked to the development of fibrotic tissue changes in the long run (Wynn 2016) and importantly, fibrotic changes have been described following strain injuries (Bayer 2021, Silder 2008). Also, as prolonged elevated TNF-α (tumor necrosis factor-α) is known as an activator of the Nuclear Factor NF-κB pathway, this could cause stimulation of muscle atrophy related genes (Cohen 2015). It appears therefore clinically relevant to ensure that the pro-inflammatory phase following strain injuries is initially undisturbed, but the continuous pro-inflammatory phase is blunted to reduce the formation of fibrosis.
The aim of the present study is to test the hypothesis that an inhibition of inflammation, combined with the best standard training regimen in the later phase of recovery after injury (day 7-14) will provide a more optimal tissue recovery after injury than training alone will do.
The overall hypothesis is that administration of NSAID in the second week after an acute muscle strain injury in otherwise healthy humans, will be beneficial for tissue healing, characterized by an improved cellular composition allowing for less scar formation in the regeneration phase.
Participants will undergo a basic physical examination, including ultrasonographic scanning of the injured muscle site and fulfill questionnaire regarding previous injury history and present activities as well as symptoms.
Participants are then randomized to either placebo or NSAID treatment (Bonyl/ Naproxen 500 mg x 2 per day for 7 days) starting on day 7 and continued until day 14 post injury.
When participants are free of pain during movement including repeated explosive movements, the duration of the injury onset until full recovery is recorded (time to return to sports). Each participant will be followed by questionnaires for one year to record potential re-injuries.
Biopsies will be taken in week 1 post injury, before the pharmacological intervention, and in week 3 post injury, after the pharmacological intervention.
Biopsies will be analyzed by single nuclei RNA sequencing. Bioinformatics will be applied to investigate the distribution and number of cells in the injured muscle. Each biopsy will be compared to the control muscle (the same muscle as the injured one on the healthy, contralateral leg).
The biopsies will be obtained with a semi-automatic equipment that is routinely used to sample tendon tissue and tissue from chronic scar area in muscle (Bard Monopty) with a diameter of 1,6 mm a length of 10 mm.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory medicine | Experimental | Drug: Naproxen 500 Mg, Procedure: RehabilitationWeek 2 after muscle strain injury Naproxen 500mg 2x daily |
| Placebo | Placebo comparator | Procedure: Rehabilitation, Drug: PlaceboWeek 2 after muscle strain injury Placebo pill, no active compounds 2x daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Needle phobia
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 |
|---|---|---|
| Naproxen 500 MgAlso: Anti-inflammatory Agents, Non-steroidalAttenuating the sub-acute inflammatory processes to monitor potential beneficial tissue healing following a muscle strain injury | Drug | Anti-inflammatory medicine |
| RehabilitationAlso: Physical therapy to stimulate tissue healingRehabilitation after muscle strain injury | Procedure or surgery | Anti-inflammatory medicine, Placebo |
| PlaceboAlso: inert pillsSub-acute inflammatory processes not attenuated. Group will be treated as control to monitor tissue healing following a muscle strain injury without pharmacological intervention. | Drug | Placebo |
Primary outcome
Effect of anti-inflammatory medicine on cellular profile in skeletal muscle
Time frame: 12 months
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.
3 secondary outcomes
Functional outcome performance
Time frame: Up to 12 months
Functional outcome re-injury rate
Time frame: 12 months
Functional outcome Patient Related Outcome Measures (PROM)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 19553225Ekstrand J, Hagglund M, Walden M. Injury incidence and injury patterns in professional football: the UEFA injury study. Br J Sports Med. 2011 Jun;45(7):553-8. doi: 10.1136/bjsm.2009.060582. Epub 2009 Jun 23.
- Background: PubMed 27184543Wangensteen A, Tol JL, Witvrouw E, Van Linschoten R, Almusa E, Hamilton B, Bahr R. Hamstring Reinjuries Occur at the Same Location and Early After Return to Sport: A Descriptive Study of MRI-Confirmed Reinjuries. Am J Sports Med. 2016 Aug;44(8):2112-21. doi: 10.1177/0363546516646086. Epub 2016 May 16.
- Background: PubMed 26526620Chazaud B. Inflammation during skeletal muscle regeneration and tissue remodeling: application to exercise-induced muscle damage management. Immunol Cell Biol. 2016 Feb;94(2):140-5. doi: 10.1038/icb.2015.97. Epub 2015 Nov 3.
- Background: PubMed 23169615Saclier M, Yacoub-Youssef H, Mackey AL, Arnold L, Ardjoune H, Magnan M, Sailhan F, Chelly J, Pavlath GK, Mounier R, Kjaer M, Chazaud B. Differentially activated macrophages orchestrate myogenic precursor cell fate during human skeletal muscle regeneration. Stem Cells. 2013 Feb;31(2):384-96. doi: 10.1002/stem.1288.
- Background: PubMed 26982353Wynn TA, Vannella KM. Macrophages in Tissue Repair, Regeneration, and Fibrosis. Immunity. 2016 Mar 15;44(3):450-462. doi: 10.1016/j.immuni.2016.02.015.
- Background: 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.
- Background: PubMed 28953439Bayer ML, Magnusson SP, Kjaer M; Tendon Research Group Bispebjerg. Early versus Delayed Rehabilitation after Acute Muscle Injury. N Engl J Med. 2017 Sep 28;377(13):1300-1301. doi: 10.1056/NEJMc1708134. No abstract available.
- Background: PubMed 30043997Bayer ML, Hoegberget-Kalisz M, Jensen MH, Olesen JL, Svensson RB, Couppe C, Boesen M, Nybing JD, Kurt EY, Magnusson SP, Kjaer M. Role of tissue perfusion, muscle strength recovery, and pain in rehabilitation after acute muscle strain injury: A randomized controlled trial comparing early and delayed rehabilitation. Scand J Med Sci Sports. 2018 Dec;28(12):2579-2591. doi: 10.1111/sms.13269. Epub 2018 Aug 16.
- Background: PubMed 23485730Silder A, Sherry MA, Sanfilippo J, Tuite MJ, Hetzel SJ, Heiderscheit BC. Clinical and morphological changes following 2 rehabilitation programs for acute hamstring strain injuries: a randomized clinical trial. J Orthop Sports Phys Ther. 2013 May;43(5):284-99. doi: 10.2519/jospt.2013.4452. Epub 2013 Mar 13.
- Background: PubMed 25549588Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
- Background: PubMed 31211922Bayer ML, Bang L, Hoegberget-Kalisz M, Svensson RB, Olesen JL, Karlsson MM, Schjerling P, Hellsten Y, Hoier B, Magnusson SP, Kjaer M. Muscle-strain injury exudate favors acute tissue healing and prolonged connective tissue formation in humans. FASEB J. 2019 Sep;33(9):10369-10382. doi: 10.1096/fj.201900542R. Epub 2019 Jun 18.
Related trials for Muscle Strain, Multiple Sites
Active, not recruiting
Nutritional Strategies After Muscle Strain Injuries
Muscle Strain, Multiple Sites
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.
Simon E Jespersen, MD contact
Michael L Kjaer, DMSCi study director
Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen 500 Mg and Rehabilitation in people with Muscle Strain, Multiple Sites and Inflammation, run by Bispebjerg Hospital.
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 2 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: opening soon, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Lucia L Bayer, PhD (+4525687931, monika.lucia.bayer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of anti-inflammatory medicine on cellular profile in skeletal muscle (time frame: 12 months). 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 NCT06274151, which also lists 11 linked publications.
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 23 Feb 2024.