Evaluating Tropho Tend for Painful Rotator Cuff Tendinopathy
Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy (RCT)
This study is testing if adding Tropho Tend injections to regular physical therapy can help people with painful rotator cuff tendinopathy feel better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mastelli S.r.l Industry-sponsored |
| Locations | 1 site (Sassuolo, Italy) |
| Trial ID | NCT06809543 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the clinical benefits and safety of Tropho Tend in managing painful Rotator Cuff Tendinopathy. Participants will be randomly assigned to either a control group receiving standard rehabilitation physiotherapy or a therapy group receiving the same physiotherapy plus Tropho Tend injections. The study will involve five visits over four months to monitor pain levels and functionality. The goal is to determine if the addition of Tropho Tend improves outcomes compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with painful Rotator Cuff Tendinopathy lasting at least six weeks and experiencing moderate to severe pain.
Not a fit: Patients with severe tendon injuries, previous surgeries, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved functionality for patients suffering from Rotator Cuff Tendinopathy.
How similar studies have performed: While the specific use of Tropho Tend is novel, similar approaches using polynucleotides for tendon injuries have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male and female patients ≥ 18 years of age, in good general health condition. * Painful Rotator Cuff Tendinopathy (RCT) since ≥ 6 weeks. * Pain and impaired functionality on a 0 to 10 cm-centimeter specifically designed Visual Analogue Scale (VAS) ≥ 4 cm at baseline visit. * Rotator Cuff Tendinopathy (RCT) diagnosis, based on clinical examination. * Tendon ultrasound (EUS) performed within one month of enrollment. * Signed written informed consent. Exclusion Criteria * Treatment with any investigational product within 6 months prior to clinical investigation entry. * Patients with known hypersensitivity to the products (active compound and excipients) or any component or procedure used in the clinical investigation. * Patients with para-tendinopathy, partial/total rupture, previous tendon surgery. * Severe intercurrent illness (e.g.: uncontrolled diabetes mellitus, peripheral neuropathy, autoimmune or inflammatory condition, metabolic disorders, severe oncological conditions) that, in the opinion of the investigator, may put the patient at risk when participating in the clinical investigation or affect the patient's ability to take part in the clinical investigation . * Patients treated with systemic and/or local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours. * Recent history of drug and/or alcohol abuse (within the last 6 months). * Pregnant or breastfeeding women
Where this trial is running
Sassuolo, Italy
- Ospedale di Sassuolo S.p.A. — Sassuolo, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia C Mastelli, MD
- Email: giulia.cattarini@mastelli.it
- Phone: +39 0184 5111 21
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.