Subacromial Impingement Syndrome Clinical Trial
Official title:
Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
Verified date | December 2013 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. — View Citation
Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;(1):CD004016. Review. — View Citation
Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. Review. — View Citation
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 6 weeks from initial injection of corticosteroid versus platelet rich plasma | No |
Primary | Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 12 weeks from initial injection of corticosteroid versus platelet rich plasma | No |
Primary | Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma | No |
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