Conservative care with or without manipulative therapy in the management of back and/or neck pain in Danish children aged 9–15: a randomised controlled trial nested in a school-based cohort

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Published online 2018 Sep 10. doi: 10.1136/bmjopen-2017-021358

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Table 3

Outcomes, definitions and statistical methods

	Definition	Statistical method
Primary outcome

Number of recurrences of spinal pain (3–27 months follow-up).	(1) A positive answer on the weekly text message for spinal pain (2) minimum of 1 week without report of spinal pain prior to the recurrence.	A hierarchical negative binomial regression model was used. Intervention effects were expressed as incidence rate ratio.

Secondary outcomes

Average duration of spinal pain episodes.	The number of consecutive weeks the child was affected by spinal pain (response option ‘1’).	A mixed-effects linear regression model with subject as random effect, outcome log transformed was used. Intervention effects were expressed as the difference in median length.
Total duration of complaint time in relation to individual follow-up time.	Total number of weeks a child was affected by spinal pain (response option ‘1’) in the entire follow-up period.	A hierarchical negative binomial regression model was used. Intervention effects were expressed as incidence rate ratio.
Global Perceived Effect after 2 weeks.	Dichotomised into two groups: ‘Much better’ and ‘The same or worse’.	A logistic regression model was used. Intervention effects were expressed as ORs.
Change in pain intensity after 2 weeks.	Rated on an 11-point Numerical Rating Scale with ‘0’ being ‘no pain’ and ‘10’ being ‘worst pain’.	A linear regression model was used. Intervention effects were expressed as the difference in mean length.