title: Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain.
abstract: OBJECTIVE
  This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP).
  
  
  METHODS
  A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale.
  
  
  RESULTS
  Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences).
  
  
  CONCLUSIONS
  Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.
authors.affiliation: Optum , Lincoln, RI.
authors.forename: Aaron
authors.initials: A
authors.lastname: Yarlas
authors.forename: Kate
authors.initials: K
authors.lastname: Miller
authors.forename: Warren
authors.initials: W
authors.lastname: Wen
authors.forename: Shau Yu
authors.initials: SY
authors.lastname: Lynch
authors.forename: Catherine
authors.initials: C
authors.lastname: Munera
authors.forename: Joseph V
authors.initials: JV
authors.lastname: Pergolizzi
authors.forename: Robert
authors.initials: R
authors.lastname: Raffa
authors.forename: Steven R
authors.initials: SR
authors.lastname: Ripa
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002047:Buprenorphine / Q000008:administration & dosage*; D059350:Chronic Pain; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine
keywords: Butrans; buprenorphine transdermal system; chronic low back pain; opioid treatment; pain interference