Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Loma Linda, California 92354


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Patients presenting with rotator cuff symptoms for at least 4 weeks 2. Examination reveals diffuse pain with provocative maneuvers 3. Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear) 4. Willingness to participate in an investigational technique 5. Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week) Exclusion Criteria: 1. Previous rotator cuff repair 2. Complete rotator cuff tear or two tendon tears 3. Pt w/ complex regional pain syndrome 4. Cervical neuropathy or other nerve pathology 5. RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy 6. Evidence of intraarticular arthritis 7. Work related or compensable injury 8. Previous treatment: corticosteroid injection in the last 6 months 9. Patients who are currently pregnant


NCT ID:

NCT01123889


Primary Contact:

Principal Investigator
Montri D Wongworawat, MD
Loma Linda University Department of Orthopedics


Backup Contact:

N/A


Location Contact:

Loma Linda, California 92354
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.