Understanding cellular mechanisms in muscle injuries
Cellular Mechanisms Involved in Pathology Following Musculo-tendinous Injuries
This study is trying to learn how certain cells in the muscles change after injuries like strains and tendon ruptures to help understand why muscles can get weaker and hurt again.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05798962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the cellular mechanisms involved in the fatty degeneration of skeletal muscle following injuries such as muscle strains and Achilles tendon ruptures. It will analyze muscle biopsies from patients with acute and chronic muscle strain injuries, as well as those with a history of Achilles tendon rupture, to identify the presence and role of fibro-adipogenic progenitors (FAPs) in muscle pathology. The study will utilize ultrasound scans to assess pathological changes in muscle tissue and correlate these findings with cellular characteristics. By understanding these mechanisms, the study seeks to shed light on the factors contributing to muscle degeneration and re-injury.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute or chronic muscle strain injuries or a history of Achilles tendon rupture.
Not a fit: Patients with diabetes, connective tissue diseases, or those who smoke daily may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for muscle injuries, potentially enhancing recovery and reducing the risk of re-injury.
How similar studies have performed: While the specific cellular mechanisms in human muscle pathology have not been extensively studied, related research on muscle injuries and degeneration has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older, male and female, with an acute muscle strain injury (\<14 days post injury) in the calf or hamstring muscles (group 1). Pathological changes visible on an ultrasound scan as hypoechoic areas. * 18 years and older, male and female, with a chronic muscle strain injury (\> 6 months prior to inclusion) in the calf or hamstring muscles (group 2), sequela including recurrent strain injuries, pain and/ or decrease in muscle function. Pathological changes visible on an ultrasound scan as hypo-/ hyperechoic areas. * 18 years and older, male and female, with a full Achilles tendon rupture (\> 1 year prior to inclusion) with pathological changes: Fatty degeneration visible on an ultrasound scan (group 3). Exclusion Criteria: * Type I and II Diabetes, Connective tissue and/or rheumatic diseases, or any observed organ dysfunctions * Daily smoking * Persons with daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within three months prior to time of contact * Allergic reactions to local anesthesia * Use of anticoagulant treatment * Needle phobia * Any drug or alcohol abuse now or in the past * The absence of any pathological changes visible on an ultrasound scan as hypo-/ hyperechoic areas (group 1 and 2) * The absence of any pathological changes (fatty degeneration) in either the gastrocnemius or the soleus muscle visible on an ultrasound scan (Subject group 3)
Where this trial is running
Copenhagen
- Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8 — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Monika L Bayer, PhD — Bispebjerg Hospital
- Study coordinator: Monika L Bayer, PhD
- Email: Monika.lucia.bayer@regionh.dk
- Phone: 004525687931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.