Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
NCT ID: NCT01833598
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-09-30
2019-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PNT + PRP
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
PNT + 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.
PNT alone
percutaneous needle tenotomy alone
PNT 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.
Interventions
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PNT + 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.
PNT 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Jonathan Kirschner, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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References
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Fredberg U, Stengaard-Pedersen K. Chronic tendinopathy tissue pathology, pain mechanisms, and etiology with a special focus on inflammation. Scand J Med Sci Sports. 2008 Feb;18(1):3-15. doi: 10.1111/j.1600-0838.2007.00746.x.
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Kirschner JS, Cheng J, Hurwitz N, Santiago K, Lin E, Beatty N, Kingsbury D, Wendel I, Milani C. Ultrasound-guided percutaneous needle tenotomy (PNT) alone versus PNT plus platelet-rich plasma injection for the treatment of chronic tendinosis: A randomized controlled trial. PM R. 2021 Dec;13(12):1340-1349. doi: 10.1002/pmrj.12583. Epub 2021 Apr 28.
Other Identifiers
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HSS 2015-189
Identifier Type: -
Identifier Source: secondary_id
2015-189
Identifier Type: -
Identifier Source: org_study_id