Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

Subacromial Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123889
• Other study ID #: 59322
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: December 24, 2013
• Start date: May 2010
• Est. completion date: May 2011

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partial Thickness Rotator Cuff Tear
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Biological:
• platelet rich plasma injection
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.

Drug:
• corticosteroid injection
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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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