Objectives: The Buprenorphine Transdermal Delivery System (BTDS) is indicated for reduction of pain in moderate-to-severe Chronic Low Back Pain (CLBP), which can affect patients' ability to perform routine activities of daily living (ADLs). This post-hoc analysis of clinical trial data examines the impact of BTDS treatment on CLBP patients' ability to perform ADLs that relate to functioning with low back pain.
Methods: Data are drawn from a multicenter, enriched enrollment, randomized, placebocontrolled, double blind 12-week trial of BTDS for pain control among opioid-naive patients with moderate-to-severe CLBP. The 23 selected ADLs are those that (1) appear in the Low Back Pain Core Set of the International Classification of Functioning, Disability and Health and (2) link to the content of three patient-reported outcome instruments administered during the trial. Logistic regression models estimated the odds ratios (ORs) of BTDS patients' ability to perform each ADL at 12 weeks, controlling for baseline ability, relative to placebo.
Results: The ORs for ten ADLs related to sleeping, lifting, bending, and working reached multiplicity-adjusted statistical significance and indicated a greater ability to perform ADLs among BTDS users than among the placebo group. These ten ORs ranged from 1.9 (no physical-health-related restrictions on the kind of work performed) to 2.4 (being able to sleep undisturbed by pain).
Discussion: These results suggest that for patients with moderate-to-severe chronic lower back pain, 12 weeks use of BTDS improves the ability to carry out certain ADLs relating to sleeping, lifting, bending, and working.
(C) 2014 by Lippincott Williams & Wilkins