- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123889
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Loma Linda University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: control
corticosteroid injection into subacromial space
|
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:
|
EXPERIMENTAL: experimental
patients will receive an injection of platelet rich plasma into the subacromial space
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks from initial injection of corticosteroid versus platelet rich plasma
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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.
|
12 weeks from initial injection of corticosteroid versus platelet rich plasma
|
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.
|
15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Montri D Wongworawat, MD, Loma Linda University Department of Orthopedics
Publications and helpful links
General Publications
- Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. doi: 10.1302/0301-620x.85b1.13846. 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. doi: 10.2106/00004623-199611000-00007.
- Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
- Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Syndrome
- Rotator Cuff Injuries
- Shoulder Impingement Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Ropivacaine
Other Study ID Numbers
- 59322
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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