Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Condition: Full Thickness Rotator Cuff Tear; Rotator Cuff Tendinitis
MeSH terms: Tendinopathy; Rotator Cuff Injuries
Intervention: Ketorolac; Marcaine (placebo); Kenalog
Intervention description: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml; Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine; Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Ketorolac; Bupivacaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the functional outcomes of patients with shoulder
      pathology treated with either ketorolac or corticosteroid injections, in a randomized
      double-blinded study. Investigators will compare the effectiveness of ketorolac compared to
      corticosteroid.

      Specific Aim 1:

      Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be
      more effective than corticosteroid injection for the treatment of a variety of shoulder
      pathologies.

      The risks associated with this study primarily concern adverse reactions to the study drugs.
      The drugs used in this study are not narcotics or habit-forming but can have side effects.
      The patient's physician will screen for any heart, intestinal, or kidney disease or condition
      that would increase the chance for the patient to have an unwanted side effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rotator Cuff Tendinitis

          -  Atraumatic Rotator Cuff Tear

          -  Rotator Cuff Tear Arthropathy

          -  Subjects who speak English

        Exclusion Criteria:

          -  Age: < 18 years old

          -  Prior Shoulder Surgery

          -  Fracture

          -  Acute Traumatic Rotator Cuff Tear

          -  Infection

          -  Uncontrolled Diabetes Mellitus (HbA1c >8)

          -  Recent Prior Shoulder Injection in either the Subacromial space

          -  Workers Compensation

          -  History of Gastric Ulcers

          -  Tumor Involving the Shoulder Region

          -  Prior history of gastrointestinal bleeding, allergic reactions, impaired renal
             function, seizures or cardiac arrhythmias

          -  Subject unable to provide informed consent

          -  Subjects who don't speak English

          -  Patients who are pregnant or lactating at time of screening or are of child bearing
             age

          -  Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory
             agents that could affect inflammation response.

          -  Patients with any bleeding disorders.

          -  Patients with severe renal failure.

          -  Patients likely to have severe problems maintaining follow-up, including patients
             diagnosed with severe psychiatric conditions, patients who live too far outside the
             hospital's catchment area, patients who are incarcerated and patients who have
             unstable housing situations.

          -  Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs