Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial

Table 8 ITT group analysis of secondary outcomes

	Outcome	PaDSMaP Mean (sd)	TAU Mean (sd)	Estimated effect^a (95% CI) (linear model, T-test)	Difference (95% CI) Adjusted by baseline^b, HADS anxiety, HADS depression (linear model, T-test)
	Time to Mobilisation	36.1 (23.4) n = 65	34.4 (21.4) n = 66	1.7(− 6.0,9.5) P = 0.661	2.8(− 5.1,10.7) P = 0.486
Intention to Treat analysis	SWP Baseline	8.87 (2.3) n = 69	8.09 (2.5) n = 68
	SWP 3 days	9.52 (2.6) n = 53	9.77 (2.7) n = 53	−0.245 (−1.3,0.77) p = 0.634	− 0.30 (− 1.36,0.77) n = 106 p = 0.578
	SWP 6 weeks	10.8 (2.8) n = 63	11.0 (3.2) n = 66	− 0.191 (− 1.2,0.86) p = 0.719	−0.25 (− 1.34,0.84) n = 127 p = 0.647
	SWI 3 days	30.1 (9.6) n = 48	31.8 (9.5) n = 54	−1.68 (−5.44,2.08) p = 0.379	−1.76 (− 5.58,2.07) n = 101 p = 0.365
	SWI 6 weeks	28.2 (10.6) n = 61	32.1 (13.5) n = 61	−3.87 (− 8.1,0.64) p = 0.093	−4.34 (− 8.87,-0.03) n = 120 p = 0.048^c
	OKS Baseline	19.0 (7.1)	18.8 (7.2)
	OKS 6 weeks	28.2 (7.2)	27.6 (8.0)	0.55 (−2.1, 3.2) p = 0.680	0.486 (−2.1,3.1) n = 130 p = 0.710

^aEstimated treatment effect of self-medication compared to TAU
^bCorresponding baseline outcome or (for SWI), VAS baseline
^cAnxiety is highly significant here P = 0.004 and reduces predicted SWI
Abbreviations: HADS – Hospital Anxiety and Depression Scale; ITT – intention to treat; OKS – Oxford Knee Scale; PaDSMaP - Patient-directed self-management of pain; SWP – Satisfaction With Pain scale; SWI – Satisfaction With Information scale; TAU – treatment as usual

ISSN: 1472-6963