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NCT Number: NCT01123889

Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

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.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Partial Thickness Rotator Cuff Tear Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma injection

Biological

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

Corticosteroid injection

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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