Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
Primary Purpose
Subacromial Impingement Syndrome, Partial Thickness Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
platelet rich plasma injection
corticosteroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma
Eligibility 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
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
experimental
Arm Description
corticosteroid injection into subacromial space
patients will receive an injection of platelet rich plasma into the subacromial space
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01123889
First Posted
April 20, 2010
Last Updated
December 24, 2013
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT01123889
Brief Title
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
Official Title
Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome, Partial Thickness Rotator Cuff Tear
Keywords
subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
corticosteroid injection into subacromial space
Arm Title
experimental
Arm Type
Experimental
Arm Description
patients will receive an injection of platelet rich plasma into the subacromial space
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma injection
Other Intervention Name(s)
platelet rich plasma - PRP, naropin, xylocaine
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
corticosteroid injection
Other Intervention Name(s)
triamcinalone, naropin, xylocaine
Intervention 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.
Primary Outcome Measure Information:
Title
Pain and Disability of the Shoulder Through Validated Questionnaires
Description
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.
Time Frame
6 weeks from initial injection of corticosteroid versus platelet rich plasma
Title
Pain and Disability of the Shoulder Through Validated Questionnaires
Description
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.
Time Frame
12 weeks from initial injection of corticosteroid versus platelet rich plasma
Title
Pain and Disability of the Shoulder Through Validated Questionnaires
Description
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.
Time Frame
15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montri D Wongworawat, MD
Organizational Affiliation
Loma Linda University Department of Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12585570
Citation
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.
Results Reference
background
PubMed Identifier
8934482
Citation
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.
Results Reference
background
PubMed Identifier
16735582
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. doi: 10.1177/0363546506288850. Epub 2006 May 30.
Results Reference
background
PubMed Identifier
12535501
Citation
Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
Results Reference
background
Learn more about this trial
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
We'll reach out to this number within 24 hrs