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A Randomized, Placebo-Controlled Study of the Impact of the 7-Day Buprenorphine Transdermal System on Health-Related Quality of Life in Opioid-Naïve Patients With Moderate-to-Severe Chronic Low Back Pain

Published:December 03, 2012DOI:https://doi.org/10.1016/j.jpain.2012.09.016

      Abstract

      This study evaluated the impact of treatment with Buprenorphine Transdermal System (BTDS) on the health-related quality of life for patients with moderate-to-severe chronic low back pain (CLBP), and the correspondence between quality of life and pain. A multicenter, enriched, double-blind (DB), placebo-controlled, randomized trial evaluated BTDS 10 and 20 μg/hour for treatment of opioid-naïve patients with moderate-to-severe CLBP. The SF-36v2 survey, which measures 8 domains of quality of life, was administered at screening and following an open-label run-in period with BTDS and at weeks 4, 8, and 12 of the DB phase. Post hoc analyses compared SF-36v2 scores between BTDS and placebo groups during the DB phase. Condition burden was examined through comparisons with a U.S. general population sample. Correlations examined the correspondence between quality of life and pain measures. BTDS produced larger improvements than placebo at 12 weeks in all quality-of-life domains (Ps < .05). Treatment group differences in both physical and mental quality of life emerged by 4 weeks. Patients' pretreatment quality of life was worse than that in the general population (Ps < .05); only BTDS treatment eliminated deficits in pain, social functioning, and role limitations due to emotional health. Improvements in quality of life were moderately associated with pain reduction. These data suggest that moderate-to-severe CLBP patients receiving BTDS exhibited better quality of life than patients receiving placebo.

      Perspective

      This post hoc analysis suggests that patients with moderate-to-severe CLBP treated with BTDS exhibit better health-related quality of life than those using placebo within 4 weeks of treatment, and were more likely to exhibit clinically meaningful improvements in quality of life following 12 weeks of treatment.

      Key words

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      References

        • Allan L.
        • Richarz U.
        • Simpson K.
        • Slappendel R.
        Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain.
        Spine (Phila Pa 1976). 2005; 30: 2484-2490
        • Andersson G.B.
        Epidemiological features of chronic low-back pain.
        Lancet. 1999; 354: 581-585
        • Balague F.
        • Mannion A.F.
        • Pellise F.
        • Cedraschi C.
        Non-specific low back pain.
        Lancet. 2012; 379: 482-491
        • Bartleson J.D.
        Evidence for and against the use of opioid analgesics for chronic nonmalignant low back pain: A review.
        Pain Med. 2002; 3: 260-271
        • Bentsen S.B.
        • Hanestad B.R.
        • Rustoen T.
        • Wahl A.K.
        Quality of life in chronic low back pain patients treated with instrumented fusion.
        J Clin Nurs. 2008; 17: 2061-2069
        • Bentsen S.B.
        • Wahl A.K.
        • Strand L.I.
        • Hanestad B.R.
        Relationships between demographic, clinical and pain variables and health-related quality of life in patients with chronic low back pain treated with instrumented fusion.
        Scand J Caring Sci. 2007; 21: 134-143
        • Bronfort G.
        • Bouter L.M.
        Responsiveness of general health status in chronic low back pain: A comparison of the COOP charts and the SF-36.
        Pain. 1999; 83: 201-209
        • Chou R.
        • Fanciullo G.J.
        • Fine P.G.
        • Adler J.A.
        • Ballantyne J.C.
        • Davies P.
        • Donovan M.I.
        • Fishbain D.A.
        • Foley K.M.
        • Fudin J.
        • Gilson A.M.
        • Kelter A.
        • Mauskop A.
        • O'Connor P.G.
        • Passik S.D.
        • Pasternak G.W.
        • Portenoy R.K.
        • Rich B.A.
        • Roberts R.G.
        • Todd K.H.
        • Miaskowski C.
        Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.
        J Pain. 2009; 10: 113-130
        • Cleeland C.S.
        • Ryan K.M.
        Pain assessment: Global use of the Brief Pain Inventory.
        Ann Acad Med Singapore. 1994; 23: 129-138
        • Devine J.
        • Norvell D.C.
        • Ecker E.
        • Fourney D.
        • Vaccaro A.
        • Wang J.
        • Andersson G.
        Evaluating the correlation and responsiveness of patient reported pain with function and quality of life outcomes after spine surgery.
        Spine (Phila Pa 1976). 2011; 36: S69-S74
        • Deyo R.A.
        • Mirza S.K.
        • Martin B.I.
        Back pain prevalence and visit rates: Estimates from U.S. national surveys, 2002.
        Spine (Phila Pa 1976). 2006; 31: 2724-2727
        • Ekman M.
        • Jonhagen S.
        • Hunsche E.
        • Jonsson L.
        Burden of illness of chronic low back pain in Sweden: A cross-sectional, retrospective study in primary care setting.
        Spine (Phila Pa 1976). 2005; 30: 1777-1785
        • Freburger J.K.
        • Holmes G.M.
        • Agans R.P.
        • Jackman A.M.
        • Darter J.D.
        • Wallace A.S.
        • Castel L.D.
        • Kalsbeek W.D.
        • Carey T.S.
        The rising prevalence of chronic low back pain.
        Arch Intern Med. 2009; 169: 251-258
        • Gordon A.
        • Callaghan D.
        • Spink D.
        • Cloutier C.
        • Dzongowski P.
        • O'Mahony W.
        • Sinclair D.
        • Rashiq S.
        • Buckley N.
        • Cohen G.
        • Kim J.
        • Boulanger A.
        • Piraino P.S.
        • Eisenhoffer J.
        • Harsanyi Z.
        • Darke A.C.
        • Michalko K.J.
        Buprenorphine transdermal system in adults with chronic low back pain: A randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase.
        Clin Ther. 2010; 32: 844-860
        • Gordon A.
        • Rashiq S.
        • Moulin D.E.
        • Clark A.J.
        • Beaulieu A.D.
        • Eisenhoffer J.
        • Piraino P.S.
        • Quigley P.
        • Harsanyi Z.
        • Darke A.C.
        Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.
        Pain Res Manag. 2010; 15: 169-178
        • Huge V.
        • Schloderer U.
        • Steinberger M.
        • Wuenschmann B.
        • Schops P.
        • Beyer A.
        • Azad S.C.
        Impact of a functional restoration program on pain and health-related quality of life in patients with chronic low back pain.
        Pain Med. 2006; 7: 501-508
        • Jaeschke R.
        • Singer J.
        • Guyatt G.H.
        Measurement of health status: Ascertaining the minimal clinically important difference.
        Control Clin Trials. 1989; 10: 407-415
        • Juniper E.F.
        • Guyatt G.H.
        • Willan A.
        • Griffith L.E.
        Determining a minimal important change in a disease-specific Quality of Life Questionnaire.
        J Clin Epidemiol. 1994; 47: 81-87
        • Katz N.
        Enriched enrollment randomized withdrawal trial designs of analgesics: Focus on methodology.
        Clin J Pain. 2009; 25: 797-807
        • Kosinski M.R.
        • Schein J.R.
        • Vallow S.M.
        • Ascher S.
        • Harte C.
        • Shikiar R.
        • Frank L.
        • Margolis M.K.
        • Vorsanger G.
        An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system.
        Curr Med Res Opin. 2005; 21: 849-862
        • Kosinski M.
        • Bayliss M.
        • Bjorner J.B.
        • Ware Jr., J.E.
        Improving Estimates of SF-36® Health Survey Scores for Respondents in Missing Data.
        Medical Outcomes Trust Monitor. 2000; 5: 8-10
        • Maruish M.E.
        User's manual for the SF-36v2 health survey.
        QualityMetric, Incorporated, Lincoln, RI2011
        • McQuay H.J.
        • Derry S.
        • Moore R.A.
        • Poulain P.
        • Legout V.
        Enriched enrolment with randomised withdrawal (EERW): Time for a new look at clinical trial design in chronic pain.
        Pain. 2008; 135: 217-220
        • Rabini A.
        • Aprile I.
        • Padua L.
        • Piazzini D.B.
        • Maggi L.
        • Ferrara P.E.
        • Amabile E.
        • Bertolini C.
        Assessment and correlation between clinical patterns, disability and health-related quality of life in patients with low back pain.
        Eura Medicophys. 2007; 43: 49-54
        • Ren X.S.
        • Selim A.J.
        • Fincke G.
        • Deyo R.A.
        • Linzer M.
        • Lee A.
        • Kazis L.
        Assessment of functional status, low back disability, and use of diagnostic imaging in patients with low back pain and radiating leg pain.
        J Clin Epidemiol. 1999; 52: 1063-1071
        • Rubin D.I.
        Epidemiology and risk factors for spine pain.
        Neurol Clin. 2007; 25: 353-371
        • Ruoff G.E.
        • Rosenthal N.
        • Jordan D.
        • Karim R.
        • Kamin M.
        Tramadol/Acetaminophen combination tablets for the treatment of chronic lower back pain: A multicenter, randomized, double-blind, placebo-controlled outpatient study.
        Clin Ther. 2003; 25: 1123-1141
        • Salaffi F.
        • De Angelis R.
        • Stancati A.
        • Grassi W.
        Health-related quality of life in multiple musculoskeletal conditions: A cross-sectional population based epidemiological study. II. The MAPPING study.
        Clin Exp Rheumatol. 2005; 23: 829-839
        • Schofferman J.
        • Mazanec D.
        Evidence-informed management of chronic low back pain with opioid analgesics.
        Spine J. 2008; 8: 185-194
        • Skljarevski V.
        • Zhang S.
        • Desaiah D.
        • Alaka K.J.
        • Palacios S.
        • Miazgowski T.
        • Patrick K.
        Duloxetine versus placebo in patients with chronic low back pain: A 12-week, fixed-dose, randomized, double-blind trial.
        J Pain. 2010; 11: 1282-1290
        • Staud R.
        • Price D.D.
        Long-term trials of pregabalin and duloxetine for fibromyalgia symptoms: How study designs can affect placebo factors.
        Pain. 2008; 136: 232-234
        • Staud R.
        • Price D.D.
        Role of placebo factors in clinical trials with special focus on enrichment designs.
        Pain. 2008; 139: 479-480
        • Steiner D.J.
        • Sitar S.
        • Wen W.
        • Sawyerr G.
        • Munera C.
        • Ripa S.R.
        • Landau C.
        Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: An enriched, randomized, double-blind, placebo-controlled study.
        J Pain Symptom Manage. 2011; 42: 903-917
        • Szczurko O.
        • Cooley K.
        • Busse J.W.
        • Seely D.
        • Bernhardt B.
        • Guyatt G.H.
        • Zhou Q.
        • Mills E.J.
        Naturopathic care for chronic low back pain: A randomized trial.
        PLoS One. 2007; 2: e919
        • Tavafian S.S.
        • Jamshidi A.R.
        • Mohammad K.
        Treatment of chronic low back pain: A randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone.
        Clin J Pain. 2011; 27: 811-818
        • Trescot A.M.
        • Helm S.
        • Hansen H.
        • Benyamin R.
        • Glaser S.E.
        • Adlaka R.
        • Patel S.
        • Manchikanti L.
        Opioids in the management of chronic non-cancer pain: An update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines.
        Pain Physician. 2008; 11: S5-S62
        • Veresciagina K.
        • Ambrozaitis K.V.
        • Spakauskas B.
        Health-related quality-of-life assessment in patients with low back pain using SF-36 questionnaire.
        Medicina (Kaunas). 2007; 43: 607-613
        • Veresciagina K.
        • Ambrozaitis K.V.
        • Spakauskas B.
        The measurements of health-related quality-of-life and pain assessment in the preoperative patients with low back pain.
        Medicina (Kaunas). 2009; 45: 111-122
        • Wallace M.
        • Thipphawong J.
        Open-label study on the long-term efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain.
        Pain Med. 2010; 11: 1477-1488
        • Yarlas A.
        • Miller K.
        • Wen W.
        • Shah R.
        • Dain B.
        • Lynch S.-Y.
        • Ripa S.R.
        The impact of Buprenorphine Transdermal System 5 mcg/hour (BTDS 5) and 20 mcg/hour (BTDS 20) on quality of life in opioid-experienced patients with moderate to severe chronic low back pain [abstract]. 56th Annual AOA Research Conference.
        J Am Osteopath Assoc. 2012; 112: 529-562