Shoulder Pain Clinical Trial
Official title:
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 years or older - History and physical examination consistent with shoulder pain and subacromial bursitis - At least 2 weeks of shoulder pain and subacromial bursitis Exclusion Criteria: - Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone - History or examination suspicious for a humeral head fracture - History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side - History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint - Any shoulder surgery involving the affected arm within the last 6 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Keesler Medical Center | Keesler AFB | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Keesler Air Force Base Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety | Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received. | 6 weeks | Yes |
Primary | Improvement in shoulder function, as measured by the QuickDASH ® | The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) | 6 weeks | No |
Secondary | Improvement in subject reported shoulder pain as measured by the Visual Analogue Scale | Improvement in shoulder pain reported by the subject after injection at 6 weeks. The patient will indicate from 0 (no pain) to 10 (maximal pain) changes in shoulder pain after injection. A 2 point change is expected. | 6 weeks | No |
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