Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

• 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.

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.

• 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

• 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.

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