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Chiropractic Treatment for Headache Among Children Aged 7-14

N

Nordic Institute of Chiropractic and Clinical Biomechanics

Status

Completed

Conditions

Chronic Headache

Treatments

Procedure: Placebo
Procedure: Chiropractic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02684916
1504 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

7 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups, including a placebo group

Chiropractic treatment
Experimental group
Description:
Visit with active treatment.
Treatment:
Procedure: Chiropractic treatment
Placebo
Placebo Comparator group
Description:
Visit without active treatment.
Treatment:
Procedure: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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