Chiropractic Treatment for Headache Among Children Aged 7-14
- Conditions
- Chronic Headache
- Interventions
- Procedure: Chiropractic treatmentProcedure: Placebo
- Registration Number
- NCT02684916
- Lead Sponsor
- Nordic Institute of Chiropractic and Clinical Biomechanics
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chiropractic treatment Chiropractic treatment Visit with active treatment. Placebo Placebo Visit without active treatment.
- Primary Outcome Measures
Name Time Method Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months. Assessed weekly for a period of four months. Patient or parent reported via sms-service.
- Secondary Outcome Measures
Name Time Method 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. Patient or parent reported via sms-service.
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. Patient or parent reported via sms-service.
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. Patient or parent reported via sms-service.
Trial Locations
- Locations (1)
Kiropraktisk Center og Børneklinik
🇩🇰Brønderslev, Denmark