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

April 20, 2010
December 24, 2013
May 2010
May 2011   (final data collection date for primary outcome measure)
  • 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.
  • 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 cortcicosteroid 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.
Complete list of historical versions of study NCT01123889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Subacromial Impingement Syndrome
  • Partial Thickness Rotator Cuff Tear
  • 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
  • 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
  • Active Comparator: control
    corticosteroid injection into subacromial space
    Intervention: Drug: corticosteroid injection
  • Experimental: experimental
    patients will receive an injection of platelet rich plasma into the subacromial space
    Intervention: Biological: platelet rich plasma injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01123889
59322
No
Montri D. Wongworawat, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Montri D Wongworawat, MD Loma Linda University Department of Orthopedics
Loma Linda University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP