Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeon (ASES)
研究概览
简要总结
The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.
详细描述
Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.
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
- Double (Participant, Investigator)
盲法说明
Neither the treating physician nor the patient will have access to drug-related details. Data will only be retrieved by the coordinating institution's research coordinator.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Severe or recalcitrant shoulder impingement syndrome
- •Subacromial injection is a therapeutic option
排除标准
- •Allergy or intolerance to steroids within less than 1 month
- •Allergy or intolerance to NSAIDs within less than 1 month
- •Pregnancy
- •Breastfeeding
- •Pre-existing asthma
- •Uncontrolled psychiatric illness
- •Previous shoulder injection within the past 3 months
- •Evidence of confounding shoulder pathology on imaging
- •History of a full-thickness rotator cuff tear
- •Ipsilateral cervical radiculopathy
- •Moderate to severe glenohumeral arthritis
- •Systemic inflammatory conditions
- •Kidney disease
- •Liver disease
- •Gastrointestinal ulcer
- •Bleeding disorder
- •Pending litigation or work-related claims related to the shoulder
- •Previous shoulder surgery on the affected shoulder
- •Evidence of local infection
- •Evidence of adhesive capsulitis
- •Evidence of shoulder instability
研究组 & 干预措施
Ketorolac
Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)
干预措施: Ketorolac Tromethamine (Drug)
Methylprednisolone
Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
干预措施: Methylprednisolone Acetate (Drug)
结局指标
主要结局
American Shoulder and Elbow Surgeon (ASES)
时间窗: 12 weeks
The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
次要结局
- American Shoulder and Elbow Surgeon (ASES)(4 weeks)
- Range of Motion (ROM)(12 weeks)