Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

• ClinicalTrials.gov Identifier: NCT01123889
• Recruitment Status: Completed
• First Posted: May 14, 2010
• Results First Posted: February 11, 2014
• Last Update Posted: February 11, 2014
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Montri D. Wongworawat, Loma Linda University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Subacromial Impingement Syndrome; Partial Thickness Rotator Cuff Tear	Biological: platelet rich plasma injection; Drug: corticosteroid injection	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
• Study Start Date: May 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: control; corticosteroid injection into subacromial space	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.; Other Names: triamcinalone; naropin; xylocaine
Experimental: experimental; patients will receive an injection of platelet rich plasma into the subacromial space	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.; Other Names: platelet rich plasma - PRP; naropin; xylocaine

Outcome Measures

Primary Outcome Measures :

1. Pain and Disability of the Shoulder Through Validated Questionnaires [ Time Frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma ]
   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.
2. Pain and Disability of the Shoulder Through Validated Questionnaires [ Time Frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma ]
   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.
3. Pain and Disability of the Shoulder Through Validated Questionnaires [ Time Frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Loma Linda University

Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Investigators

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

More Information

Publications:

Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. Review.

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.

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.

Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;(1):CD004016. Review.

• Responsible Party: Montri D. Wongworawat, Professor, Loma Linda University
• ClinicalTrials.gov Identifier: NCT01123889
• Other Study ID Numbers: 59322
• First Posted: May 14, 2010
• Results First Posted: February 11, 2014
• Last Update Posted: February 11, 2014
• Last Verified: December 2013

Keywords provided by Montri D. Wongworawat, Loma Linda University:

subacromial impingement; partial thickness rotator cuff; PRP; platelet rich plasma

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries; Disease; Pathologic Processes; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases; Lidocaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action