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Tests treatment safety and results for Rotator Cuff Tendinopathy
Official title Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy
ClinicalTrials.gov ID: NCT06809543
What this study is testing
- What it's testing
- This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT). All subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Patients treated with systemic and/or local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of...
- Recent history of drug and/or alcohol abuse (within the last 6 months).
See the full eligibility 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.
- 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...
- 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...
- Recent history of drug and/or alcohol abuse (within the last 6 months).
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Sassuolo, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sassuolo, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.