NCT01032720终止不适用
Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections
VA Connecticut Healthcare System1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Compare the effectiveness of US-guided vs. sham US CS intra-articular knee injections as measured by a 10-point between groups difference in the Knee injury and Osteoarthritis Outcome score (KOOS).
研究概览
简要总结
To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 40 and
- •Meet the American College of Rheumatology criteria for knee OA with knee pain, aching or stiffness on most of the past 30 days and have evidence on radiograph of a definite osteophyte.
- •Have a pain score of at least 4 out of 10 on an 11 point numeric rating scale.
- •For participants with bilateral knee OA, the most symptomatic knee will be considered the study knee. If both knees are symptomatic, the subject will choose the one they want treated.
- •Be able to speak and understand English.
- •Have a telephone.
排除标准
- •Prior hyaluronic acid injection.
- •Scheduled knee hyaluronic acid injections, arthroscopy, or knee surgery.
- •Comorbid conditions including: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain, knee instability defined as report of knee buckling or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent
- •Current involvement in litigation or receiving workmen's compensation. These patients are to be excluded because they are expected to bias results. This group will be expected to over-report pain symptoms. This bias cannot be corrected for in the analysis.
- •Contraindications to intra-articular injections: known bleeding disorder/diathesis.
- •Prosthesis in the painful knee.
- •Bilateral total knee replacements.
- •Pregnancy if no recent knee x-rays are available.
- •Wheelchair bound.
- •BMI greater than 40.
研究组 & 干预措施
Ultrasound-guided knee CS injection
Experimental
Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.
干预措施: Ultrasound (Procedure)
Sham Ultrasound knee CS injection
Sham Comparator
CS knee injection will be performed in the same method as the US-guided knee injection but the US machine will be turned off.
干预措施: Sham ultrasound (Procedure)
结局指标
主要结局
Compare the effectiveness of US-guided vs. sham US CS intra-articular knee injections as measured by a 10-point between groups difference in the Knee injury and Osteoarthritis Outcome score (KOOS).
时间窗: 4 weeks
次要结局
- Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.(2, 6, and 8 weeks)
- Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.(2, 4, 6, and 8 weeks)
- Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain.(2, 4, 6, and 8 weeks)
- Compare the effectiveness of US-guided vs. sham US knee injections in reducing the use of co-therapies (acetaminophen, nonsteroidal anti-inflammatory drugs, and narcotics)(2, 4, 6, and 8 weeks)
- Examine whether body mass index, presence or absence of chronic widespread pain, radiographic severity, patient expectations, patient satisfaction, and dispositional optimism predict response to CS injections.(2, 4, 6, and 8 weeks)
研究者
研究点 (1)
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