NCT02684916

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Headache

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-02-18
• Last updated: 2020-03-09

Locations

1 site across 1 country: Denmark