Patient education booklet to support evidence-based low back pain care in primary care – a cluster randomized controlled trial

Simula, Anna S.; Jenkins, Hazel J.; Hancock, Mark J.; Malmivaara, Antti; Booth, Neill; Karppinen, Jaro

doi:10.1186/s12875-021-01529-2

Table 4 Patient reported outcomes

From: Patient education booklet to support evidence-based low back pain care in primary care – a cluster randomized controlled trial

Outcome	Time	Intervention group n (total n = 145)	Control group n (total n = 161)	Intervention group Mean^a (SE)	Control group Mean^a (SE)	Mean difference^b (95% CI)	P value	Age-adjusted mean difference^b (95% CI)	P value
PROMIS T-score^b	Baseline	139	152	44.7 (0.6)	43.8 (0.6)	0.9 (-0.7 to 2.6)	0.271	0.5 (-1.1 to 2.1)	0.526
	Change 3 m	84	95	2.5 (0.7)	1.5 (0.7)	1.0 (-1.5 to 3.5)	0.365	0.93 (-1.0 to 2.9)	0.346
	Change 12 m	67	91	2.2 (0.9)	2.3 (0.7)	-0.1 (-2.3 to 2.1)	0.923	0.09 (-2.3 to 2.2)	0.935
Low back pain intensity during last week (NRS, 0–10) ^b	Baseline	145	161	5.1 (0.3)	4.8 (0.3)	0.29 (-0.8 to 1.3)	0.521	0.38 (-0.7 to 1.5)	0.427
	Change 3 m	91	105	-0.6 (0.5)	-0.4 (0.5)	-0.3 (-2.1 to 1.5)	0.732	-0.3 (-2.1 to 1.5)	0.695
	Change 12 m	79	105	-1.8 (0.5)	-1.3 (0.5)	-0.47 (-2.1 to 1.2)	0.517	-0.5 (-2.2 to 1.1)	0.462
Leg pain intensity during last week LN [(NRS 0–10) + 0.5]^e ^b	Baseline	145	161	0.9 (0.1)	0.9 (0.1)	0.1 (-0.4 to 0.5)	0.805	0.1 (-0.4 to 0.6)	0.708
	Change 3 m	91	105	-0.2 (0.2)	0.01 (0.2)	-0.2 (-0.8 to 0.4)	0.407	-0.2 (-0.8 to 0.4)	0.395
	Change 12 m	79	105	0.4 (0.2)	-0.2 (0.1)	-0.1 (-0.7 to 0.4)	0.506	-0.2 (-0.7 to 0.4)	0.491
ODI%^b	Baseline	145	161	23.5 (1.3)	24.0 (1.2)	-0.5 (-4.0 to 3.1)	0.795	0.2 (-3.4 to 3.7)	0.925
	Change 3 m	91	105	-5.1 (1.8)	-3.4 (1.7)	-1.7 (-7.6 to 4.1)	0.501	-1.7 (-7.6 to 4.1)	0.511
	Change 12 m	79	104	-5.7 (2.4)	-4.1 (2.2)	-1.6 (-10.1 to 6.9)	0.645	-1.7 (-10.2 to 6.7)	0.619
EQ5D-3L index^db	Baseline	145	161	0.659 (0.023)	0.664 (0.022)	-0.005 (-0.089 to 0.080)	0.890	< 0.001 (< 0.001 to 0.084)	0.807
	Change 12 m	79	107	0.048 (0.029)	0.053 (0.025)	0.005 (-0.081 to 0.071)	0.894	-0.007 (-0.083 to 0.070)	0.859
Self-rated health EQ5D-VAS (0–100)^b	Baseline	144	159	68.2 (2.5)	67.1 (2.4)	1.1 (-7.3 to 9.4)	0.771	0.5 (-7.9 to 8.8)	0.899
	Change 12 m	75	103	5.4 (2.4)	5.6 (2.1)	-0.1 (-6.5 to 6.2)	0–970	0.03 (-6.4 to 6.4)	0.992
				% (n)	% (n)	OR (95% CI)		OR (95% CI)
LBP frequency (daily LBP yes/no)^c	Baseline	147	161	43.4 (63)	50.9 (82)	0.79 (0.57 to 1.09)	0.143	0.80 (0.55 to 1.16);	0.244
	3 months			38.7 (36)	42.6 (46)	0.94 (0.61 to 1.44)	0.768	0.94 (0.50 to 1.49)	0.792
	12 months	83	107	28.9 (24)	32.7 (35)	0.85 (0.48 to 1.51)	0.586	0.84 (0.48 to 1.49)	0.560

Presented as intervention group vs control group. ^aValues estimated from least square means with standard error. ^bLeast square mean difference estimated from linear mixed model with random effects for unit. Positive and negative mean differences indicate higher and lower values among intervention group, respectively. ^cDifference between intervention and control groups analyzed with logistic regression using generalized estimating equations with exchangeable working correlation matrix
Change 3 m calculated from baseline to 3-month follow-up and change 12 m from baseline to 12-month follow-up
^dUK TTO
NRS (Numeral rating scale), ODI (Oswestry Disability Index), PROMIS T-score (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form T-score), EQ5D-3L index (EuroQol five dimensions, 3-level version)
^eLN (natural logarithmic) transformation for Leg pain intensity used because of positively skewed distribution

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