NCT02610504已完成不适用
A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Shoulder pain on movement (SPOM) 0-100mm VAS
研究概览
简要总结
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
详细描述
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of glenohumeral osteoarthritis
- •SPOM score greater than or equal to 50 in study shoulder
- •Willing to discontinue oral and topical analgesia other than rescue acetaminophen
- •abstinence from any other IA or per-articular injections for the shoulder during the course of the trial
- •patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month
- •pain at least 50% of the days during previous month
- •patients who have failed conventional therapy of NSAIDs or steroid injections
- •patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder
- •cooperative and able to communicate effectively
- •agree not to participate in any other studies during trial
排除标准
- •significant pain from other joints requiring chronic analgesic therapy
- •presence of one or more conditions besides OA that could confound pain and functional assessments
- •clinically apparent tense effusion, malalignment or instability in study shoulder
- •shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity
- •inability to abstain from analgesic use other than rescue acetaminophen
- •IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month
- •IA injection of hyaluronic acid in the study shoulder within 9 months of baseline
- •allergic reaction to HA
- •any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder
- •uncontrolled hypothyroidism
- •pregnant or breastfeeding women
- •planned surgical procedure
- •history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site
- •treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline
结局指标
主要结局
Shoulder pain on movement (SPOM) 0-100mm VAS
时间窗: over 26 weeks
次要结局
- Shoulder pain at night (SPAN) 0-100mm VAS(over 26 weeks)
- Adverse events, concomitant medications, physical exam(over 26 weeks)
- American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form(over 26 weeks)
- Patient Global Assessment (PGA)(over 26 weeks)
- Shoulder pain rescue medication diary(over 26 weeks)
研究者
研究点 (1)
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