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

NCT01600326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-05

Study results available
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Summary

The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Conditions

  • Tendinosis
  • Tendinitis

Interventions

PROCEDURE

Tenotomy (no injection)

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.

DRUG

Ultrasound guided platelet rich plasma injection

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.

Sponsors & Collaborators

Principal Investigators

  • Jon Jacobson, MD · University of Michigan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-07-31
Completion
2015-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600326 on ClinicalTrials.gov