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, placebo-controlled, 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 3 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 10 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 10 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 CLBP, 12 weeks use of BTDS improves the ability to carry out certain ADLs related to sleeping, lifting, bending, and working.
*Optum, Lincoln, RI
†Purdue Pharma LP, Stamford, CT
‡Department of Medicine, Johns Hopkins University, Baltimore, MD
§Department of Anesthesiology, Georgetown University School of Medicine, Washington, DC
∥Department of Pharmacology, Temple University School of Medicine
¶Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, PA
Funded by Purdue Pharma, LP. This research received no support from NIH, Wellcome Trust, or the Howard Hughes Medical Institute. K.M. and A.Y. are full-time employees of Optum, which received payment from Purdue Pharma, LP to analyze the data and develop the manuscript. W.W., B.D., S.Y.L., and S.R.R. are full-time employees of Purdue Pharma, LP. The remaining authors declare no conflict of interest.
Reprints: Kate Miller, PhD, MPH, Optum, 24 Albion Road, Bldg. 400, Lincoln, RI 02865 (e-mail: email@example.com).
Received June 14, 2013
Received in revised form February 18, 2014
Accepted December 26, 2013