Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
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ClinicalTrials.gov Identifier: NCT01833598 |
Recruitment Status :
Completed
First Posted : April 17, 2013
Last Update Posted : December 23, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Tendinopathy | Procedure: PNT + PRP Procedure: PNT alone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Ultrasound Guided Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis |
Actual Study Start Date : | September 2012 |
Actual Primary Completion Date : | June 2019 |
Actual Study Completion Date : | June 2019 |
Arm | Intervention/treatment |
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Active Comparator: PNT + PRP
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
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Procedure: 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.
Other Name: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection |
Active Comparator: PNT alone
percutaneous needle tenotomy alone
|
Procedure: 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 Name: percutaneous needle tenotomy alone |
- Improvement in pain based on a visual analog score [ Time Frame: Week 2 ]
- Improvement in pain based on a visual analog score [ Time Frame: Week 4 ]
- Improvement in pain based on a visual analog score [ Time Frame: Week 6 ]
- Improvement in pain based on a visual analog score [ Time Frame: Week 8 ]
- Improvement in pain based on a visual analog score [ Time Frame: Week 12 ]
- Activity Level [ Time Frame: Week 2 ]Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
- Activity Level [ Time Frame: Week 4 ]Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
- Activity Level [ Time Frame: Week 6 ]Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
- Activity Level [ Time Frame: Week 8 ]Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
- Activity Level [ Time Frame: Week 12 ]Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
- Complications [ Time Frame: Week 2 ]bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
- Complications [ Time Frame: Weeks 4 ]bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
- Complications [ Time Frame: Weeks 6 ]bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
- Complications [ Time Frame: Weeks 8 ]bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
- Complications [ Time Frame: Weeks 12 ]bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
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currently are or plan to become pregnant during the study.
- Patients taking aspirin or NSAIDs are not excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833598
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Jonathan Kirschner, MD | Hospital for Special Surgery, New York |
Responsible Party: | Hospital for Special Surgery, New York |
ClinicalTrials.gov Identifier: | NCT01833598 |
Other Study ID Numbers: |
2015-189 HSS 2015-189 |
First Posted: | April 17, 2013 Key Record Dates |
Last Update Posted: | December 23, 2020 |
Last Verified: | November 2020 |
Chronic tendinopathy platelet rich plasma tendonitis percutaneous tendon tenotomy pain |
shoulder knee ankle foot |
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |