Polynucleotide biogel enhances tissue repair, matrix deposition and organization.
M T Colangelo, P Govoni, S Belletti...
https://pubmed.ncbi.nlm.nih.gov/33480222Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06809543
Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy
Led by Mastelli S.r.l · Updated on 2026-02-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the clinical benefits and safety of Tropho Tend in treating painful Rotator Cuff Tendinopathy (RCT). This study compares two groups: one receiving standard rehabilitation physiotherapy and another receiving rehabilitation physiotherapy plus Tropho Tend injections. The investigation is open label and controlled, aiming to assess improvements in pain and function over a 4-month period with 5 scheduled visits. Participants are randomly assigned to either the control group receiving rehabilitation physiotherapy alone or the therapy group receiving Tropho Tend injections in addition to physiotherapy. Tropho Tend is given as three perilesional injections spaced two weeks apart, starting at the baseline visit. Ultrasound evaluations of the tendon are performed at the beginning and end of the study to observe changes. During the study, participants have visits at baseline, 2, 4, 8, and 12 weeks. Pain levels, shoulder function, and patient satisfaction are regularly assessed using tools like the Visual Analogue Scale (VAS), Shoulder Pain and Disability Index (SPADI), and Single Assessment Numeric Evaluation (SANE). Quality of life and adverse events are monitored throughout. The total study duration includes screening, treatment, follow-up, and data analysis, concluding about one year after starting.
CONDITIONS
Brief Title
Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years of age or older in good general health
- Painful Rotator Cuff Tendinopathy lasting at least 6 weeks
- Pain and impaired function with a Visual Analogue Scale (VAS) score of 4 cm or higher at baseline
- Diagnosis of Rotator Cuff Tendinopathy based on clinical examination
- Tendon ultrasound performed within one month before enrollment
- Signed written informed consent
You will not qualify if you...
- Treatment with any investigational product within 6 months before study entry
- Known hypersensitivity to study products or any components used in the study
- Para-tendinopathy, partial or total tendon rupture, or previous tendon surgery
- Severe illnesses such as uncontrolled diabetes, peripheral neuropathy, autoimmune or inflammatory conditions, metabolic disorders, or severe cancer that may pose risk or affect participation
- Use of systemic or local steroids within 6 months, immunosuppressive drugs within 3 months, frequent NSAIDs within 1 week, or occasional NSAIDs within 24 hours
- Recent history of drug or alcohol abuse within 6 months
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive three injections of Tropho Tend at the muscular-tendineal or osteo-tendineal junctions and undergo rehabilitation physiotherapy as standard care.
3 visits for Tropho Tend injections at baseline, 2 weeks, and 4 weeks
Follow-up
Duration - 12 weeks after end of treatment
Participants are monitored for pain, function, tendon ultrasound appearance, quality of life, and adverse events after the treatment ends.
Follow-up visits at 8 and 12 weeks after treatment completion
Trial Site Locations
Total: 1 location
1
Ospedale di Sassuolo S.p.A.
Sassuolo, Italy, Italy, 41049
Actively Recruiting
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Research Team
G
Giulia C Mastelli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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