Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montri D. Wongworawat, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01123889
First received: April 20, 2010
Last updated: December 24, 2013
Last verified: December 2013
  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:


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 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 [ 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 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 [ 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 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.


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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Montri D. Wongworawat, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01123889     History of Changes
Other Study ID Numbers: 59322
Study First Received: April 20, 2010
Results First Received: October 31, 2013
Last Updated: December 24, 2013
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:
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014