Original Report| Volume 12, ISSUE 2, P288-296, February 2011

Download started.


A Randomized Trial of 2 Prescription Strategies for Opioid Treatment of Chronic Nonmalignant Pain

Published:November 29, 2010DOI:


      The use of opioid medications for treating chronic noncancer pain is growing; however, there is a lack of good evidence regarding their long-term effectiveness, association with substance abuse, and proper prescribing guidelines. The current study directly compares for the first time in a randomized trial the effectiveness of a conservative, hold the line (Stable Dose) prescribing strategy for opioid medications with a more liberal dose escalation (Escalating Dose) approach. This 2-arm, parallel, randomized pragmatic clinical trial followed 135 patients referred to a specialty pain clinic at a Veterans Affairs Hospital for 12 months (94% male and 74% with musculoskeletal pain). Primary outcomes included monthly or quarterly evaluations of pain severity, pain relief from medications, pain-related functional disability, and opioid misuse behaviors. All subjects received identical pain treatment except for the application of treatment group specific strategies for opioid prescriptions. No group differences were found for primary outcomes of usual pain or functional disability although the Escalating Dose group did show a small but significantly larger increase in self-rated pain relief from medications. About 27% of patients were discharged over the course of the study due to opioid misuse/noncompliance, but there were no group differences in rate of opioid misuse.


      The results of this study demonstrate that even in carefully selected patients there is a significant risk of problematic opioid misuse. Although in general there were no statistically significant differences in the primary outcomes between groups, the escalating dose strategy did lead to small improvements in self-reported acute relief from medications without an increase in opioid misuse, compared to the stable dose strategy.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to The Journal of Pain
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Ballantyne J.C.
        Opioids for chronic pain: Taking stock.
        Pain. 2006; 125: 3-4
        • Chou R.
        • Ballantyne J.C.
        • Fanciullo G.J.
        • Fine P.G.
        • Miaskowski C.
        Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline.
        J Pain. 2009; 10: 147-159
        • 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
        • Deshpande A.
        • Furlan Andrea D.
        • Mailis-Gagnon A.
        • Atlas S.
        • Turk D.
        Opioids for Chronic Low-Back Pain. Cochrane Database of Systematic Reviews.
        John Wiley & Sons, Ltd, Chichester, UK2007
        • Fairbank J.C.
        • Couper J.
        • Davies J.B.
        • O’Brien J.P.
        The Oswestry low back pain disability questionnaire.
        Physiotherapy. 1980; 66: 271-273
      1. Fairbank JC, Pynsent PB: The Oswestry Disability Index. Spine 25:2940-2952; discussion 52, 2000

        • First M.B.
        • Spitzer R.L.
        • M. G
        • Williams J.B.W.
        Structured Clinical Interview for DSM-IV Axis I Disorders, Clinician Version (SCID-CV), 1st ed.
        American Psychiatric Press, Inc., Washington, DC1996
        • Franklin G.M.
        • Rahman E.A.
        • Turner J.A.
        • Daniell W.E.
        • Fulton-Kehoe D.
        Opioid use for chronic low back pain: A prospective, population-based study among injured workers in Washington state, 2002-2005.
        Clin J Pain. 2009; 25: 743-751
        • Gilson A.M.
        • Ryan K.M.
        • Joranson D.E.
        • Dahl J.L.
        A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002.
        J Pain Symptom Manage. 2004; 28: 176-188
        • Kalso E.
        • Edwards J.E.
        • Moore R.A.
        • McQuay H.J.
        Opioids in chronic non-cancer pain: Systematic review of efficacy and safety.
        Pain. 2004; 112: 372-380
        • Landau S.
        • Everitt B.
        A Handbook of Statistical Analyses Using SPSS.
        Chapman & Hall/CRC, Boca Raton, FL2004
        • Lauridsen H.H.
        • Hartvigsen J.
        • Manniche C.
        • Korsholm L.
        • Grunnet-Nilsson N.
        Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients.
        BMC Musculoskelet Disord. 2006; 7: 82
        • Martell B.A.
        • O’Connor P.G.
        • Kerns R.D.
        • Becker W.C.
        • Morales K.H.
        • Kosten T.R.
        • Fiellin D.A.
        Systematic review: Opioid treatment for chronic back pain: Prevalence, efficacy, and association with addiction.
        Ann Intern Med. 2007; 146: 116-127
      2. Naliboff B, Wu S, Schieffer B, Pham Q, Baria A, Van Vort W, Davis F, Bolus R, Shekelle P: A prospective trial of opiate prescribing strategies for chronic pain. J Pain 8:S44, 2007

        • Passik S.D.
        • Kirsh K.L.
        Opioid therapy in patients with a history of substance abuse.
        CNS Drugs. 2004; 18: 13-25
      3. Principles. Principles of Analgesic Use in the Treatment of Acute and Cancer Pain.
        5th ed. The American Pain Society, Glenview, IL1999
        • Schieffer B.M.
        • Pham Q.
        • Labus J.
        • Baria A.
        • Van Vort W.
        • Davis P.
        • Davis F.
        • Naliboff B.D.
        Pain medication beliefs and medication misuse in chronic pain.
        J Pain. 2005; 6: 620-629
        • Singer J.D.
        • Willett J.B.
        Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence, 1st ed.
        Oxford University Press, New York, NY2003
        • Sundwall D.N.
        • Rolfs R.
        • Johnson E.
        Utah clinical guidelines on prescribing opioids for treatment of pain.
        Utah Department of Health. 2009;
        • Weissman D.E.
        • Haddox J.D.
        Opioid pseudoaddiction–an iatrogenic syndrome.
        Pain. 1989; 36: 363-366
        • Wu S.M.
        • Compton P.
        • Bolus R.
        • Schieffer B.
        • Pham Q.
        • Baria A.
        • Van Vort W.
        • Davis F.
        • Shekelle P.
        • Naliboff B.D.
        The addiction behaviors checklist: Validation of a new clinician-based measure of inappropriate opioid use in chronic pain.
        J Pain Symptom Manage. 2006; 32: 342-351