Expired Study
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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


Study is Available At:


Original ID:

59322


NCT ID:

NCT01123889


Secondary ID:


Study Acronym:


Brief Title:

Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection


Official Title:

Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Loma Linda University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:May 2010
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 29, 2011
First Received Date:April 20, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pain and Disability of the Shoulder through Validated Questionnaires
Time Frame:6 weeks from initial injection of corticosteroid versus platelet rich plasma
Safety Issues:False
Description:Patients will be asked to fill out 4 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, a constant score, a UCLA shoulder score, and the American Shoulder and Elbow Societ
Outcome Type:Primary Outcome
Measure:Pain and Disability of the Shoulder through Validated Questionnaires
Time Frame:12 weeks from initial injection of corticosteroid versus platelet rich plasma
Safety Issues:False
Description:Patients will be asked to fill out 4 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, a Constant score, a UCLA shoulder score, and the American Shoulder and Elbow Societ
Outcome Type:Primary Outcome
Measure:Pain and Disability of the Shoulder through Validated Questionnaires
Time Frame:15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Safety Issues:False
Description:Patients will be asked to fill out 4 questionnaires in the clinic as a baseline assessment. These questionnaires consist of a visual analog pain score, a constant score, a UCLA shoulder score, and the American Shoulder and Elbow Society score. All these q

Study Interventions

Intervention Type:Drug
Name:corticosteroid injection
Description:Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
Arm Name:control
Other Name:triamcinalone
Intervention Type:Biological
Name:platelet rich plasma injection
Description:45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The pa
Arm Name:experimental
Other Name:platelet rich plasma - PRP

Study Arms

Study Arm Type:Experimental
Arm Name:experimental
Description:patients will receive an injection of platelet rich plasma into the subacromial space
Study Arm Type:Active Comparator
Arm Name:control
Description:corticosteroid injection into subacromial space

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Loma Linda University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;(1):CD004016. Review.
PMID:12535501
Reference Type:Reference
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.
PMID:16735582
Reference Type:Reference
Citation: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.
PMID:8934482
Reference Type:Reference
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. No abstract available.
PMID:12585570

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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