Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

December 22, 2020 updated by: Hospital for Special Surgery, New York

The Efficacy of Ultrasound Guided Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10029
        • Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PNT + PRP
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
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 Names:
  • 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 Names:
  • percutaneous needle tenotomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in pain based on a visual analog score
Time Frame: Week 2
Week 2
Improvement in pain based on a visual analog score
Time Frame: Week 4
Week 4
Improvement in pain based on a visual analog score
Time Frame: Week 6
Week 6
Improvement in pain based on a visual analog score
Time Frame: Week 8
Week 8
Improvement in pain based on a visual analog score
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Level
Time Frame: Week 2
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Week 2
Activity Level
Time Frame: Week 4
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Week 4
Activity Level
Time Frame: Week 6
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Week 6
Activity Level
Time Frame: Week 8
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Week 8
Activity Level
Time Frame: Week 12
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Week 12
Complications
Time Frame: Week 2
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Week 2
Complications
Time Frame: Weeks 4
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Weeks 4
Complications
Time Frame: Weeks 6
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Weeks 6
Complications
Time Frame: Weeks 8
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Weeks 8
Complications
Time Frame: Weeks 12
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Weeks 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Jonathan Kirschner, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-189
  • HSS 2015-189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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