Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Number of recurrences during the follow-up period.
研究概览
简要总结
The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.
详细描述
Parents receive text messages [SMS) on a weekly basis inquiring about the child's musculoskeletal pain as well as amount and types of sport during leisure time the past week. Following a report of pain, the parents will be interviewed by phone by a member of the clinical team, consisting of two licensed physical therapists and two licensed chiropractors, for a thorough description of the complaint. Based on this, the interviewer determines whether the complaint is negligible or whether the child should be seen by a member of the clinical team, in which case the child will be examined at his or her school. At this examination, the child will be evaluated for inclusion and exclusion criteria.
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
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.
排除标准
- •If a serious pathology or injury is suspected, the child will be referred to a secondary care sports injury center for diagnostic work-up and/or imaging.
- •Handicaps which prevents normal physical activity.
结局指标
主要结局
Number of recurrences during the follow-up period.
时间窗: 2 1/2 year
Weekly reports of pain by sms
次要结局
- Global perceived effect after two weeks(2 weeks)
- Change in pain intensity (Numerical Rating Scale)(After one and two weeks)
- Average duration of complaint time for each episode(Up till 2 1/2 years)
- Total duration of complaint time during the follow-up period (combination of duration and recurrences)(2 1/2 year)
研究者
Kristina Boe Dissing
Principal Investigator
University of Southern Denmark