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

Primary Purpose

Chronic Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PNT + PRP
PNT alone
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tendinopathy focused on measuring Chronic tendinopathy, platelet rich plasma, tendonitis, percutaneous tendon tenotomy, pain, shoulder, knee, ankle, foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital for Special Surgery
  • Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PNT + PRP

PNT alone

Arm Description

percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

percutaneous needle tenotomy alone

Outcomes

Primary Outcome Measures

Improvement in pain based on a visual analog score
Improvement in pain based on a visual analog score
Improvement in pain based on a visual analog score
Improvement in pain based on a visual analog score
Improvement in pain based on a visual analog score

Secondary Outcome Measures

Activity Level
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Activity Level
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Activity Level
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Activity Level
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Activity Level
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Complications
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Complications
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Complications
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Complications
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Complications
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

Full Information

First Posted
April 12, 2013
Last Updated
December 22, 2020
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT01833598
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tendinopathy
Keywords
Chronic tendinopathy, platelet rich plasma, tendonitis, percutaneous tendon tenotomy, pain, shoulder, knee, ankle, foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNT + PRP
Arm Type
Active Comparator
Arm Description
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Arm Title
PNT alone
Arm Type
Active Comparator
Arm Description
percutaneous needle tenotomy alone
Intervention Type
Procedure
Intervention Name(s)
PNT + PRP
Other Intervention Name(s)
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PNT alone
Other Intervention Name(s)
percutaneous needle tenotomy alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in pain based on a visual analog score
Time Frame
Week 2
Title
Improvement in pain based on a visual analog score
Time Frame
Week 4
Title
Improvement in pain based on a visual analog score
Time Frame
Week 6
Title
Improvement in pain based on a visual analog score
Time Frame
Week 8
Title
Improvement in pain based on a visual analog score
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Activity Level
Description
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Time Frame
Week 2
Title
Activity Level
Description
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Time Frame
Week 4
Title
Activity Level
Description
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Time Frame
Week 6
Title
Activity Level
Description
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Time Frame
Week 8
Title
Activity Level
Description
Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.
Time Frame
Week 12
Title
Complications
Description
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Time Frame
Week 2
Title
Complications
Description
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Time Frame
Weeks 4
Title
Complications
Description
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Time Frame
Weeks 6
Title
Complications
Description
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Time Frame
Weeks 8
Title
Complications
Description
bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke
Time Frame
Weeks 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Kirschner, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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