Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Disease Activity Index
研究概览
简要总结
Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. Additionally to conventional drugs one third of pediatric CIBD patients use alternative treatment strategies. However, there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the disease activity and inflammation. Therefore, the main aim of this study is to evaluate the effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are non-invasive validated instruments to measure the disease activity. Furthermore, this study aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters of inflammation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild/moderate CIBD
- •stable pharmacological treatment at least for 8 weeks
排除标准
- •complementary alternative medicine
结局指标
主要结局
Disease Activity Index
时间窗: At beginning vs 4 weeks
Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
次要结局
- C reactive protein(At beginning vs 8 weeks)
- Leukocytes(At beginning vs 8 weeks)
- Erythrocyte sedimentation rate(At beginning vs 8 weeks)
- Quality of Life in Children and Adolescents measured by KINDL(R)(At beginning vs 8 weeks)
- Quality of Life in Children and Adolescents measured by ILK(At beginning vs 8 weeks)
- Pain assessment(At beginning vs 8 weeks)
研究者
Christina Hafner
Christina Hafner
Medical University of Vienna