Chronic Tendinopathy
Conditions
Keywords
Chronic tendinopathy, platelet rich plasma, tendonitis, percutaneous tendon tenotomy, pain, shoulder, knee, ankle, foot
Brief summary
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 nonhealing 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.
Interventions
PROCEDUREPNT + PRP
The PNT + PRP group will undergo needle tenotomy under direct and continuous ultrasound guidance with even distribution of PRP into the peritendinous area(s) of PNT around the affected tendon.
PROCEDUREPNT alone
The PNT group will undergo needle tenotomy under direct and continuous ultrasound guidance local anesthesia into the affected tendon. 10 minutes after the injection, the ultrasound machine probe will be passed over the areas treated both to evaluate for any structural changes and for any complications.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* aged 18-100 years * pain (≥ 5/10 pain on the VAS) 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 will be confirmed by clinical and ultrasonographic examination by the PI * ≥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)
Exclusion criteria
* taking coumadin or other anti-coagulant 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 illness such as vasculitis, an autoimmune or an inflammatory disease, or uncontrolled diabetes * presence of other musculoskeletal injury or tendon rupture in the region * currently are or plan to become pregnant during the study. * Patients taking aspirin or NSAIDs are not excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in pain based on a visual analog score | Week 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Level | Week 2 | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. |
| Complications | Week 2 | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke |
Countries
United States
Outcome results
None listed