Evaluating Tropho Tend Injections Added to Physiotherapy for Painful Rotator Cuff Tendinopathy in Adults

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.

Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy