NCT01833598.

Trial name or title	Percutaneous needle tenotomy (PNT) versus platelet rich plasma (PRP) with PNT in the treatment of chronic tendinosis
Methods	Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: single blind (subject)
Participants	Location: Icahn School of Medicine at Mount Sinai Target sample size (N): 86 Inclusion criteria: aged 18‐100 years; with pain (≥ 5/10 pain on the VAS) that is a direct result of tendinopathy as determined by history of injury and study team member physician's best judgment; ≥3 months of pain after injury that has failed conservative treatments or after corticosteroid treatment (must be 3 months after corticosteroid injection to avoid theoretical tendon rupture) Exclusion criteria: taking coumadin; known coagulopathy or bleeding dyscrasia listed by patient report (patients will be asked if they have a bleeding disorder) and/or past medical history; taking fluoroquinolones; prior PNT or PRP for the affected tendon(s); known systemic illness such as vasculitis; an autoimmune or an inflammatory disease; uncontrolled diabetes; presence of other musculoskeletal injury or tendon rupture; pregnant or planning to become pregnant during the study. Those taking aspirin or NSAIDs are not excluded
Interventions	PRP: percutaneous needle tenotomy with peritendinous platelet rich plasma injection Controls or placebo or no intervention (standard care): percutaneous needle tenotomy (alone)
Outcomes	Primary outcomes: pain Secondary outcomes: activity level, complications Timing of outcomes measurement: 2, 4, 6, 8, 12 weeks
Starting date	Main ID: NCT01833598 Date of registration: April 2013 Last refreshed on: July 2013 Date of first enrolment: September 2012 Status: enrolling participants
Contact information	Name: Alexandra Voigt Address: Icahn School of Medicine at Mount Sinai Telephone: +972 2126 599379 Email: Alexandra.voigt@mountsinai.org Affiliation: Mount Sinai School of Medicine
Notes