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A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection

Primary Purpose

Tendinosis, Tendinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tenotomy (no injection)
Ultrasound guided platelet rich plasma injection
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult subjects with a diagnosis of tendinosis of the hip.
  • Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.

Exclusion Criteria:

  • pregnancy
  • risk of bleeding due to anticoagulant medication
  • presence of malignancy
  • steroid injection less than 3 months before enrollment

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tenotomy Group

Plasma Injection Group

Arm Description

Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.

Treatment is Ultrasound guided platelet rich plasma injection.

Outcomes

Primary Outcome Measures

Pain Level and Interference With Activity
Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference. A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis. Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).

Secondary Outcome Measures

Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).

Full Information

First Posted
May 1, 2012
Last Updated
February 20, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01600326
Brief Title
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
Official Title
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
Detailed Description
Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinosis, Tendinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenotomy Group
Arm Type
Active Comparator
Arm Description
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Arm Title
Plasma Injection Group
Arm Type
Active Comparator
Arm Description
Treatment is Ultrasound guided platelet rich plasma injection.
Intervention Type
Procedure
Intervention Name(s)
Tenotomy (no injection)
Intervention Description
Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided platelet rich plasma injection
Intervention Description
Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm. The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection." Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study. Subjects will see their referring physician two weeks after treatment to begin physical therapy.
Primary Outcome Measure Information:
Title
Pain Level and Interference With Activity
Description
Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference. A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis. Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).
Time Frame
Up to 23 days
Secondary Outcome Measure Information:
Title
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
Description
Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).
Time Frame
15 to 555 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects with a diagnosis of tendinosis of the hip. Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy. Exclusion Criteria: pregnancy risk of bleeding due to anticoagulant medication presence of malignancy steroid injection less than 3 months before enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Jacobson, MD
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection

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