Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain

Table 2 Change in patient-reported outcomes – double-blind treatment period

Instrument	LS Mean Change
Instrument	Placebo	ALO-02	Difference^a	p-value
Short Form-36v2 Health Survey
Physical Functioning	−2.06	−1.44	0.62	0.5181
Role-Physical	−2.56	−2.59	−0.03	0.9733
Bodily Pain	−5.07	−2.69	2.37	0.0100
General Health	−1.55	−2.10	−0.55	0.4712
Vitality	−1.62	−2.77	−1.16	0.2898
Social Functioning	−3.17	−1.69	1.48	0.1565
Role-Emotional	−2.57	−3.44	−0.86	0.5220
Mental Health	−2.95	−2.93	0.02	0.9865
Physical Component Score	−2.70	−1.68	1.02	0.2491
Mental Component Score	−2.29	−2.98	−0.69	0.5219
EuroQol 5-Dimensions 3-Level
Summary Index	−0.061	−0.029	0.032	0.0605
Visual Analog Scale	−3.61	−2.89	0.72	0.7196
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
Percentage work time missed due to low back pain	6.49	3.72	−2.77	0.4944
Percentage impairment while working due to low back pain	6.77	4.39	−2.38	0.6008
Percentage overall work impairment due to low back pain	10.85	5.71	−5.14	0.3604
Percentage activity impairment due to low back pain	10.56	6.41	−4.15	0.1031

ALO-02 extended-release oxycodone and sequestered naltrexone, LS least squares
^aDifference calculated as ALO-02 minus placebo; a positive difference favors ALO-02, and a negative difference favors placebo for SF-36v2 and EQ-5D-3L; a negative difference favors ALO-02 for WPAI:SHP

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