Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in Shoulder Function, as Measured by the QuickDASH ®
研究概览
简要总结
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.
详细描述
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects.
Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection.
Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Methylprednisolone, 20 mg
Methylprednisolone, 20 mg, will be injected
干预措施: Methylprednisolone, 40 mg (Drug)
Triamcinolone, 20 mg
Triamcinolone, 20 mg, will be injected
干预措施: Triamcinolone, 40 mg (Drug)
Methylprednisolone, 40 mg
Methylprednisolone, 40 mg, will be injected
干预措施: Methylprednisolone, 20 mg (Drug)
Triamcinolone, 40 mg
Triamcinolone, 40 mg, will be injected
干预措施: Triamcinolone, 20 mg (Drug)
结局指标
主要结局
Change in Shoulder Function, as Measured by the QuickDASH ®
时间窗: 6 weeks
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)
次要结局
- Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale(6 weeks)