Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection - Full Text View

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.

Condition	Intervention
Subacromial Impingement Syndrome Partial Thickness Rotator Cuff Tear	Biological: platelet rich plasma injection Drug: corticosteroid injection

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma

Resource links provided by NLM:

MedlinePlus related topics: Shoulder Injuries and Disorders Steroids

Drug Information available for: Lidocaine hydrochloride Lidocaine Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

Pain and Disability of the Shoulder through Validated Questionnaires [ Time Frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
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 Society score. All these questionnaires are externally validated clinical outcome measures that rate shoulder pain, function, range of motion, strength and patient satisfaction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome.
Pain and Disability of the Shoulder through Validated Questionnaires [ Time Frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
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 Society score. All these questionnaires are externally validated clinical outcome measures that rate shoulder pain, function, range of motion, strength and patient satisfaction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome.
Pain and Disability of the Shoulder through Validated Questionnaires [ Time Frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
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 questionnaires are externally validated clinical outcome measures that rate shoulder pain, function, range of motion, strength and patient satisfaction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome.

Enrollment:	12
Study Start Date:	May 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients presenting with rotator cuff symptoms for at least 4 weeks
Examination reveals diffuse pain with provocative maneuvers
Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
Willingness to participate in an investigational technique
Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)

Exclusion Criteria:

Previous rotator cuff repair
Complete rotator cuff tear or two tendon tears
Pt w/ complex regional pain syndrome
Cervical neuropathy or other nerve pathology
RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
Evidence of intraarticular arthritis
Work related or compensable injury
Previous treatment: corticosteroid injection in the last 6 months
Patients who are currently pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123889

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. No abstract available.

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 Wongworawat, Loma Linda University Department of Orthopedics
ClinicalTrials.gov Identifier:	NCT01123889 History of Changes
Other Study ID Numbers:	59322
Study First Received:	April 20, 2010
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Loma Linda University:

subacromial impingement
partial thickness rotator cuff
PRP
platelet rich plasma

Additional relevant MeSH terms:

Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013