Overview

This trial is active, not recruiting.

Conditions tendinosis, tendinitis
Treatments tenotomy, ultrasound guided platelet rich plasma injection
Sponsor University of Michigan
Start date July 2010
End date December 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
Subjects randomized to this group will complete a pretreatment pain assessment survey which should take 15 min. to complete. Subjects will also have blood drawn from an arm vein. Follow-up by principal investigator who will contact the subject by telephone or email on day 14 and day 30 to complete the pain assessment survey questionnaire. Subjects will be asked to avoid non steroidal anti inflammatory medications for 2 weeks prior to enrollment. 2 weeks after enrollment in study, subjects will see their referring physician to begin physical therapy.
(Active Comparator)
Treatment is an ultrasound guided injection of platelet-rich plasma injection.
ultrasound guided platelet rich plasma injection
Subjects will have an ultrasound performed and blood drawn from an arm vein. The drawn blood is spun in a centrifuge to separate the blood cells from the fluid, or plasma. The plasma is used for injection into the tendon. Under sterile conditions the subject will be given a local anesthetic, lidocaine. A pain assessment survey will be completed before the procedure. The primary investigator will also contact the subject via telephone or by email on day 14 and day 30 to complete the pain assessment questionnaire. Subject will be asked to avoid any non steroidal anti inflammatory medications for 2 weeks before and 2 weeks after enrollment unless other medical conditions require their use. Subjects will also be asked to 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 August 2016.
Information provided to ClinicalTrials.gov by University of Michigan.