Subacromial Bursitis Clinical Trial
Official title:
Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Verified date | July 2014 |
Source | Keesler Air Force Base Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
To date no trials have been performed looking at whether or not intra-bursal injection of an IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving pain but this information was presented as a case series in a letter to the editor format, so the validity of these results would require additional testing [Omoigui S, et al. 2004]. Based mainly on the data from the intra-articular administration of anakinra, there have not been any adverse trends in outcomes or safety to suggest that intra-bursal injection of rilonacept will carry an increase risk of adverse events. The purpose of this trial is to compare the improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).
Status | Completed |
Enrollment | 33 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 18 years of age or older and at a minimum have a recent history (more than 3 days worth) of shoulder pain with moderate to severe tenderness to palpation over the subacromial bursa. Exclusion Criteria: - Allergies to lidocaine, marcaine, or kenalog. - Allergies to rilonacept - Flare of active inflammatory arthritis (such as a flare of Rheumatoid Arthritis) - Gout or Pseudogout attack of the shoulder with subacromial tenderness - Active infection - Actively receiving chemotherapy, radiation therapy, or anticipating surgery for neoplasia - Active myocardial infarction - Clinical and/or radiographic evidence of a fracture (clavicular, humeral, or other). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, 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 |
---|---|---|---|---|
Primary | Improvement in Shoulder Function | The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: < 15 = no problem, 16 - 40 = problem, but working, > 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7. | 4 weeks | No |
Secondary | Improvement in Pain | Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life). | 4 weeks | No |
Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded. | 4 weeks | No |
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