Clinical trial NCT01833598: Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
Official title: The Efficacy of Ultrasound Guided Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tendinopathy
Keywords: Chronic tendinopathy
platelet rich plasma
tendonitis
percutaneous tendon tenotomy
pain
shoulder
knee
ankle
foot
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in pain based on a visual analog score
timeFrame: Week 2
measure: Improvement in pain based on a visual analog score
timeFrame: Week 4
measure: Improvement in pain based on a visual analog score
timeFrame: Week 6
measure: Improvement in pain based on a visual analog score
timeFrame: Week 8
measure: Improvement in pain based on a visual analog score
timeFrame: Week 12
Secondary outcomes:
measure: Activity Level
timeFrame: Week 2
measure: Activity Level
timeFrame: Week 4
measure: Activity Level
timeFrame: Week 6
measure: Activity Level
timeFrame: Week 8
measure: Activity Level
timeFrame: Week 12
measure: Complications
timeFrame: Week 2
measure: Complications
timeFrame: Weeks 4
measure: Complications
timeFrame: Weeks 6
measure: Complications
timeFrame: Weeks 8
measure: Complications
timeFrame: Weeks 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jonathan Kirschner, MD
role: PRINCIPAL_INVESTIGATOR
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