Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- ASES Scores at Each Time Point
研究概览
简要总结
This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.
详细描述
The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
- •those who have failed previous treatment including over-the-counter analgesics and activity modification
- •have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.
排除标准
- •Patients will be excluded from the study for any of the following reasons:
- •Post traumatic osteoarthritis
- •Inflammatory osteoarthritis
- •Imaging confirmed rotator cuff tear
- •Prior ipsilateral shoulder surgery
- •Memory loss or inability to complete study measures
- •History of allergy to injection medications
- •Diabetic patients with patient-reported fasting blood glucose >200
- •Prior injection in the ipsilateral shoulder within three months
研究组 & 干预措施
symptomatic primary osteoarthritis of the shoulder
Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder
干预措施: intraarticular corticosteroid injections (IACSI) (Procedure)
symptomatic primary osteoarthritis of the shoulder
Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder
干预措施: corticosteroid injections (Drug)
symptomatic primary osteoarthritis of the shoulder
Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder
干预措施: Ultrasound (Device)
结局指标
主要结局
ASES Scores at Each Time Point
时间窗: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).
Visual Analog Scale Scores at Each Time Point.
时间窗: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
VAS (Visual Analog Scale) pain score improvement \> 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.
SST (Simple Shoulder Test) Scores at Each Time Point
时间窗: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
SST (Simple Shoulder Test) score improvement \> 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)
次要结局
未报告次要终点