drugset / Trial / NCT01123889

Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

NCT01123889

Completed 12 enrolled Loma Linda University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.

Timeline

Start
2010-05
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet Rich Plasma Other / unclassified 5 ml Other
Comparator Triamcinolone Acetonide Other / unclassified 1 ml Other
Background Lidocaine Other / unclassified 1 ml Other
Background Lidocaine Other / unclassified 2 ml Other
Background Ropivacaine Other / unclassified 1 ml Other
Background Ropivacaine Other / unclassified 2 ml Other