NCT03690466已完成不适用
Ultrasound Treatment of Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
研究概览
简要总结
The research objective of the pilot study is to assess early feasibility of safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include:
- Measure RA disease activity and functional/biomarker metrics during and after a 2- week course of spleen-directed daily ultrasound treatments (within-arm and between-arm assessments); and
- Monitor adverse events during and after daily ultrasound treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and Females aged 18 and over.
- •Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010_revised_criteria_classification_ra.pdf).
- •Classification as "definite RA" is based on the confirmed presence of synovitis in at least one joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1).
- •Exhibiting symptoms or signs of inadequate disease control according to one of 2 measures:
- •Modified HAQ score of greater than 0.3 and DAS28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP).
- •Participants should have home access to broadband internet, such that online video conversations can occur with study personnel via study-provided personal digital assistive devices.
排除标准
- •Active bacterial or viral infection.
- •Pregnant women or presence of active malignancy.
- •Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.
结局指标
主要结局
Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
时间窗: Day 0 (baseline) to Day 14 (end of treatment)
Full p-value of 0.05 will be allocated to Primary Outcome Measure and then if outcome is satisfied, the full p-value of 0.05 will be allocated to Secondary Outcome Measure.
次要结局
- Between-arm change in the DAS-28 from baseline to end of treatment.(Day 0 (baseline) to Day 14 (end of treatment))
研究者
研究点 (2)
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