Effectiveness of behavioural graded activity compared with physiotherapy treatment in chronic neck pain: design of a randomised clinical trial [ISRCTN88733332]

Table 2 Overview of variables measured in this study

Variable	Time Measured						Range of unit
	T0	T4	T9	Ts	T26	T52
Inclusion and exclusion variables	x
Demographic variables	x
Baseline variables
Specific complaint characteristics	x
Experience of the neck complaint and functioning in daily activities	x						1–7 (Likert scale)
Co-morbidity	x
Additional complaints	x
Primary outcome
'Global perceived effect' (neck complaint and functioning in daily activities) [31]		x	x	x	x	x	1–7 (Likert scale)
Secondary outcomes
Main complaint [29]	x	x	x	x	x	x	0–10 (Likert scale)
Pain (VAS) [31]	x	x	x	x	x	x
Medical consumption	x	x	x	x	x	x	Dose per day
Coping with Multi-dimensional pain (MPI) Part I-II [32]	x		x		x	x	0–6 (Likert scale)
Activity (MPI, part III)	x	x	x	x	x	x	0–6 (likert scale)
Specific functional status (NDI) [33]	x	x	x	x	x	x
Quality of life (SF-36) [34, 35]	x		x		x	x
(EQ-5d) [35, 36]	x	x	x	x	x	x
Work activities	x		x		x	x	Hours/week
Satisfaction about treatment		x	x	x	x		1–5 (Likert scale)
Compliance with treatment exercise		x	x	x	x	x	Number and time per week
Additional treatments		x	x	x	x	x	Discipline and number of treatments
Side-effects		x	x	x	x	x	Yes – No and any additional elucidation
Psychological (prognostic) variables
Fear of movement (TSK) [37]	x				x	x	1–4 (likert scale)
Catastrophizing (PCS) [38]	x		x		x		1–5 (likert scale)
Depression (CES-D) [39]	x		x		x		1–4 (likert scale)
Self-efficacy (PSEQ) [40]	x	x	x	x	x	x	10–100% (very unsure – very sure)
Stages of change (PSOCQ) [41]	x		x				1–5 (likert scale)

Note: T₀ = baseline measurement, T₄, T₉, (T_S), T₂₆, T₅₂ are follow-up measurements at 4, 9, 26 and 52 weeks, respectively, after randomisation. Ts was received at the end of treatment, when treatment lasted longer than 9 weeks. MPI, Multidimensional Pain inventory; NDI, Neck Disability Index; SF-36, Short Form 36; EQ-5d, Euroquol 5-Dutch language version; TSK, Tampa Scale for Kinesiophobia; PCS, Pain Catastrophizing Scale; CES-D, Centre for Epidemiologic Studies – Depression; PSEQ, Pain Self-Efficacy Scale; PSOCQ, Pain Stages Of Change Questionnaire.

ISSN: 1471-2474