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Table 1 Inclusion and exclusion criteria with their respective time points

From: Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7–14 years, Protocol for a randomized clinical trial

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

  1. *Time points for checking inclusion and exclusion criteria: 1 = prior to start of four weeks pretreatment period; 2 = prior to screening visit; 3 = at screening visit