Institutional Review Board, Hospital for Special Surgery
January 23, 2015
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
David A. Spinner, DO
Dallas J. Kingsbury, MD
Alexandra Voigt, BA
Julian R. Harrison, BS
Kwadwo Boachie-Adjei, CPH, BS
Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a non-healing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed.
The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.
This study entails 2 years of follow-up. We anticipate enrolling 37 study participants here at Hospital for Special Surgery.
Pain that is a direct result of tendinosis as determined by history of injury and study team member physician’s best judgment and review of medical records, imaging studies, etc.
Tendinosis confirmed by clinical and ultrasound examination
≥3 months of pain after injury that has failed conservative treatments or after corticosteroid (CSI) (must be 3 months after CSI to avoid theoretical tendon rupture)
Taking Coumadin or other anticoagulant or anti-platelet medication
Known coagulopathy or bleeding dyscrasia
Current or recent fluoroquinolone prescription
Prior PNT or PRP for the affected tendon(s)
Known systemic illnesses such as:
autoimmune or inflammatory disease
Presence of other musculoskeletal injury or tendon rupture in the region
Currently are or plan to become pregnant during the study