Clinical trial NCT02684916: Chiropractic Treatment for Headache Among Children Aged 7-14
Official title: Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Headache
Keywords: Chiropractic spinal manipulation
Children
Pediatric
Headache
Lead sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2016-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.
timeFrame: Assessed weekly for a period of four months.
Secondary outcomes:
measure: 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.
timeFrame: Assessed weekly for a period of four months.
measure: Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months.
timeFrame: Assessed weekly for a period of four months.
measure: Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months.
timeFrame: Assessed at the end of four months follow-up.
Other outcomes:
Locations:
city: Brønderslev
country: Denmark
facility: Kiropraktisk Center og Børneklinik
Study officials:
affiliation: Nordic Institute of Chiropractic and Clinical Biomechanics
name: Susanne L. Rosing, D.C., MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynge S, Dissing KB, Vach W, Christensen HW, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial. Chiropr Man Therap. 2021 Jan 7;29(1):1. doi: 10.1186/s12998-020-00360-3.
citation: Lynge S, Hartvigsen J, Christensen HW, Vach W, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial. Chiropr Man Therap. 2019 Aug 23;27:40. doi: 10.1186/s12998-019-0262-y. eCollection 2019.