Background
Method
Procedures
Recruitment
Setting and pre-randomization procedure
Inclusion criteria | Time point for checking* |
---|---|
7–14 years old | 1 |
at least one episode of headache per week for at least half a year prior to the pre-treatment period | 2 |
At least one musculoskeletal dysfunction identified by the primary investigator as a movement restriction in one or more of the joints suitable for chiropractic manipulation treatment at the time of the initial screening. | 3 |
written informed consent from the holder(s) of custody | 1 |
a mobile telephone in the family and ability to report weekly headache data | 1 |
ability to read and speak Danish at an adequate level to comply with study requirements | 2 |
Exclusion criteria
| |
contraindications for joint manipulation (Additional file 3) | 3 |
receiving any treatment by a health care professional for headache within the last three months. The only exception being prescription pain medication | 2 |
failure to report baseline data during four weeks prior to randomization | 2 |
Clinical baseline examination
Randomization
Interventions
Chiropractic manipulation
Sham manipulation
Blinding
Collection of data
Baseline data
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age
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sex
-
duration and frequency of headache problem prior to inclusion
-
characteristics of headache problem
-
prior examinations and/or treatment of headache
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family history of headache
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trauma to head and/or neck prior to inclusion
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neck and/or back pain
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other health problems
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diet, sleep and exercise habits
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sports
-
socioeconomic status
-
smoking in the home
Outcome data
Additional information collected during the trial period by the chiropractor
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number of treatments
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articulations treated (recorded at each visit)
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numbers, severity and character of traumas/accidents experienced between visits while participating in the trial (recorded at each visit)
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side effects experienced between two treatments (type, timing and duration; recorded at each visit)
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other diseases reported/identified during treatment period
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number and reasons for drop-out
Variables
Primary outcomes
Secondary outcomes
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Character and duration of side effects experienced after treatment
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Headache status after 1 year (questionnaire)
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General perceived effect after 8 months for children reporting little effect, no effect or worsening of headache in the final SMS after the treatment period and subsequently received care from the pediatrician if they had received chiropractic manipulation, or a course of chiropractic manipulation if they had received sham manipulation
Follow-up procedures after the treatment period
Sample size considerations
Statistical analyses
mi
command) considering simultaneously all outcomes and baseline variables. Analyses of data will be conducted by a researcher, otherwise not involved in the project and who will be blind for the group coding. The clinical investigators will not be involved in the analyses.