Chiropractic Treatment for Headache Among Children Aged 7-14

Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Headache
• Intervention / Treatment: Procedure: Chiropractic treatment; Procedure: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Brønderslev, Denmark, 9700
    • Kiropraktisk Center og Børneklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chiropractic treatment; Visit with active treatment.	Procedure: Chiropractic treatment; The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits. The parents and the child are unaware of group allocation.
Placebo Comparator: Placebo; Visit without active treatment.	Procedure: Placebo; Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.	Patient or parent reported via sms-service.	Assessed weekly for a period of four months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patient or parent reported via sms-service.	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.	Patient or parent reported via sms-service.	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.	Patient or parent reported via sms-service.	Assessed at the end of four months follow-up.

Collaborators and Investigators

• Sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Susanne L. Rosing, D.C., MSC, Nordic Institute of Chiropractic and Clinical Biomechanics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Children; Pediatric; Headache; Chiropractic spinal manipulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: 1504 (OTHER: CSL Behring)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No