Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.
研究概览
简要总结
The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.
详细描述
The study is a two-armed parallel, randomized controlled clinical trial where children suffering from chronic headache and at the same time having one or more biomechanical dysfunctions of the spine are randomized to either chiropractic manipulation treatment or placebo manipulation treatment.
The outcome is based on weekly sms responses collecting the number of days with headache the past week, intensity of headache and use of medication for headache. These are answered four weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up, a final questionnaire is completed including information about the course and the present headache status.
The primary outcome is the number of days with headache. Secondary outcomes are intensity of headaches and use of medication for headache.
Covariates are collected via baseline questionnaires on patient demographics; medical history; factors known to initiate, worsen or ease the headache; prevalence of headache in the nearest family; and behavioral patterns known to influence headache.
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
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Headaches for at least half a year.
- •Headache for at least 4 days pr. month.
- •At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
- •Able to report information on headache via cell phone either by him- or herself or with help from the parents.
排除标准
- •Contraindications for chiropractic treatment
- •Ongoing treatment for headache at another practitioner, except medical treatment 3 months prior to inclusion.
- •Lack of reporting baseline data via sms 4 weeks prior to inclusion.
- •Acute neck or head trauma during the trial period which is estimated to influence the headache
结局指标
主要结局
Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.
时间窗: Assessed weekly for a period of four months.
Patient or parent reported via sms-service.
次要结局
- Intensity of headache, graded on a 0-10 scale, where 10 is the worst, over four months analyzed as repeated measures with end-point at four months.(Assessed weekly for a period of four months.)
- Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months.(Assessed weekly for a period of four months.)
- Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months.(Assessed at the end of four months follow-up.)