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

Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

Sponsors

Lead sponsor: Loma Linda University

Source Loma Linda University
Brief 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.

Overall Status Completed
Start Date May 2010
Completion Date May 2011
Primary Completion Date May 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain and Disability of the Shoulder Through Validated Questionnaires 6 weeks from initial injection of corticosteroid versus platelet rich plasma
Pain and Disability of the Shoulder Through Validated Questionnaires 12 weeks from initial injection of corticosteroid versus platelet rich plasma
Pain and Disability of the Shoulder Through Validated Questionnaires 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Enrollment 12
Condition
Intervention

Intervention type: Biological

Intervention 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 patient will be monitored for 10 minutes in clinic for adverse reactions.

Arm group label: experimental

Intervention type: Drug

Intervention 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 group label: control

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 89 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Montri D Wongworawat, MD Principal Investigator Loma Linda University Department of Orthopedics
Location
facility
Loma Linda University
Location Countries

United States

Verification Date

December 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Loma Linda University

Investigator full name: Montri D. Wongworawat

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: control

Arm group type: Active Comparator

Description: corticosteroid injection into subacromial space

Arm group label: experimental

Arm group type: Experimental

Description: patients will receive an injection of platelet rich plasma into the subacromial space

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov