2023-510309-16-00招募中3 期
PAmidronate for Pain in Sternocostoclavicular hyperostosis: the PAPS-study, a double-blind randomized placebo-controlled trial (PAPS)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months
研究概览
简要总结
To demonstrate that in CNO patients with pain 3-monthly treatment with pamidronate will result in a significant decrease in maximal pain score (as measured by Brief Pain Inventory (BPI) (10), compared to placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •NRS score for maximal pain of ≥ 6/10 at lesion sites
- •Signs of disease activity on imaging at lesion sites
- •No treatment with bisphosphonates for the previous 6 months
排除标准
- •Age below 18 years of age
- •Mental disability
- •Active pregnancy wish, pregnancy or nursing
- •Generalized pain without CNO related pain
- •Bisphosphonate allergy
- •Estimated glomerular filtration rate < 30 ml/min
- •Uncontrolled endocrine abnormalities
- •Active cancer treatment
- •Language barrier
- •Severe co-morbidity, including poor mobility and other causes preventing attendance for control visits
结局指标
主要结局
Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months
Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months
次要结局
- Spinal involvement
- Cost-effectiveness
- Change in range of motion
- Number of patients with mild pain (maximal pain as measured with NRS score in BPI ≤4)
- Number of patients with 50% reduction in maximal pain (NRS score in BPI)
- Change in shoulder rating questionnaire and facets of SFA score (among which are ability to dress)
- Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden
- Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment
- Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion
- Evaluation of a possible neuropathic component of the reported pain
- Number of CNO patients exhibiting signs of central sensitization
- Association between central sensitization and therapeutic response
- Change in biochemical markers of inflammation
- Amount of tracer uptake of CNO lesions on Na18F-PET/CT
研究者
E.M. Winter
Scientific
Academisch Ziekenhuis Leiden
研究点 (1)
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