A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
|Tendinosis Tendinitis||Procedure: Tenotomy (no injection) Drug: Ultrasound guided platelet rich plasma injection||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis|
- Pain Level and Interference With Activity [ Time Frame: Up to 23 days ]
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).
- Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart [ Time Frame: 15 to 555 days post treatment ]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).
|Actual Study Start Date:||July 2010|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Tenotomy Group
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
Active Comparator: Plasma Injection Group
Treatment is Ultrasound guided platelet rich plasma injection.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600326
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Jon Jacobson, MD||University of Michigan Hospital|