Overview

This trial has been completed.

Conditions tendinosis, tendinitis
Treatments tenotomy (no injection), ultrasound guided platelet rich plasma injection
Sponsor University of Michigan
Collaborator McMaster University
Start date July 2010
End date July 2015
Trial size 30 participants
Trial identifier NCT01600326, HUM00039445

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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 14 and day 30 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.
(Active Comparator)
Treatment is Ultrasound guided platelet rich plasma injection.
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 14 and day 30 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 Outcomes

Measure
Tenotomy
time frame: 30 days

Secondary Outcomes

Measure
Effectiveness of the PRP (platelet rich plasma) injection.
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis
Principal investigator Jon Jacobson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Michigan.