Rescaling pain intensity measures for meta-analyses of analgesic medicines for low back pain appears justified: an empirical examination from randomised trials
Tóm tắt
Meta-analyses of analgesic medicines for low back pain often rescale measures of pain intensity to use mean difference (MD) instead of standardised mean difference for pooled estimates. Although this improves clinical interpretability, it is not clear whether this method is justified. Our study evaluated the justification for this method. We identified randomised clinical trials of analgesic medicines for adults with low back pain that used two scales with different ranges to measure the same construct of pain intensity. We transformed all data to a 0–100 scale, then compared between-group estimates across pairs of scales with different ranges. Twelve trials were included. Overall, differences in means between pain intensity measures that were rescaled to a common 0–100 scale appeared to be small and randomly distributed. For one study that measured pain intensity on a 0–100 scale and a 0–10 scale; when rescaled to 0–100, the difference in MD between the scales was 0.8 points out of 100. For three studies that measured pain intensity on a 0–10 scale and 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.2 points out of 100 (range 5.5 points lower to 2.7 points higher). For two studies that measured pain intensity on a 0–100 scale and a 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points out of 100 (range 6.2 points lower to 12.1 points higher). Finally, for six studies that measured pain intensity on a 0–100 scale and a 0–4 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points (range 5.4 points lower to 8.3 points higher). Rescaling pain intensity measures may be justified in meta-analyses of analgesic medicines for low back pain. Systematic reviewers may consider this method to improve clinical interpretability and enable more data to be included. Open Science Framework (osf.io/8rq7f).
Tài liệu tham khảo
Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, et al. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018;159(3):481–95.
Chapman JR, Norvell DC, Hermsmeyer JT, Bransford RJ, DeVine J, McGirt MJ, et al. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine. 2011;36:S54–68.
Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: a randomized clinical trial. JAMA. 2015;314(15):1572–80.
Kamper SJ, Grootjans SJ, Michaleff ZA, Maher CG, McAuley JH, Sterling M. Measuring pain intensity in patients with neck pain: does it matter how you do it? Pain Pract. 2015;15(2):159–67.
Litcher-Kelly L, Martino SA, Broderick JE, Stone AA. A systematic review of measures used to assess chronic musculoskeletal pain in clinical and randomized controlled clinical trials. J Pain. 2007;8(12):906–13.
Cohen J. Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Routledge; 2013.
Hedges LV, Olkin I. Statistical Methods for Meta-Analysis. Elsevier; 1985.
Thorlund K, Walter SD, Johnston BC, Furukawa TA, Guyatt GH. Pooling health-related quality of life outcomes in meta-analysis-a tutorial and review of methods for enhancing interpretability. Res Synth Methods. 2011;2(3):188–203.
Furukawa TA. From effect size into number needed to treat. Lancet. 1999;353(9165):1680.
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (updated 2022). Cochrane; 2011.
Ferraro MC, Bagg MK, Wewege MA, Cashin AG, Leake HB, Rizzo RRN, et al. Efficacy, acceptability, and safety of antidepressants for low back pain: a systematic review and meta-analysis. Syst Rev. 2021;10(1):62.
Ferreira GE, McLachlan AJ, Lin C-WC, Zadro JR, Abdel-Shaheed C, O’Keeffe M, et al. Efficacy and safety of antidepressants for the treatment of back pain and osteoarthritis: systematic review and meta-analysis. BMJ. 2021;372:m4825.
Bagg MK, McLachlan AJ, Maher CG, Kamper SJ, Williams CM, Henschke N, et al. Paracetamol, NSAIDS and opioid analgesics for chronic low back pain: a network meta‐analysis. Cochrane Database Syst Rev. 2018(6):CD013045.
Wewege MA, Bagg MK, Jones MD, McAuley JH, Cashin AG, Day RO, et al. Analgesic medicines for adults with low back pain: protocol for a systematic review and network meta-analysis. Syst Rev. 2020;9(1):255.
Abdel Shaheed C, Maher CG, Williams KA, Day R, McLachlan AJ. Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain: a systematic review and meta-analysis. JAMA Intern Med. 2016;176(7):958–68.
Abdel Shaheed C, Maher CG, Williams KA, McLachlan AJ. Efficacy and tolerability of muscle relaxants for low back pain: systematic review and meta-analysis. Eur J Pain. 2017;21(2):228–37.
Machado GC, Maher CG, Ferreira PH, Day RO, Pinheiro MB, Ferreira ML. Non-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis. Ann Rheum Dis. 2017;76(7):1269–78.
Machado GC, Maher CG, Ferreira PH, Pinheiro MB, Lin C-WC, Day RO, et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ. 2015;350:h1225.
Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database Syst Rev. 2016;6:Cd012230.
Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database of Systematic Reviews. 2021;9:CD009790.
Hayden JA, Ellis J, Ogilvie R, Stewart SA, Bagg MK, Stanojevic S, et al. Some types of exercise are more effective than others in people with chronic low back pain: a network meta-analysis. J Physiother. 2021;67(4):252–62.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073–93.
Viechtbauer W. Conducting meta-analyses in r with the metafor package. J Stat Softw. 2010;36(3):1–48.
Cloutier C, Taliano J, O’Mahony W, Csanadi M, Cohen G, Sutton I, et al. Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: a placebo-controlled, randomized study. Pain Res Manag. 2013;18(2):75–82.
Dreiser R, Marty M, Ionescu E, Gold M, Liu J. Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial. Int J Clin Pharmacol Ther. 2003;41(9):375–85.
Eken C, Serinken M, Elicabuk H, Uyanik E, Erdal M. Intravenous paracetamol versus dexketoprofen versus morphine in acute mechanical low back pain in the emergency department: a randomised double-blind controlled trial. Emerg Med J. 2014;31(3):177–81.
Friedman BW, Holden L, Esses D, Bijur PE, Choi HK, Solorzano C, et al. Parenteral corticosteroids for emergency department patients with non-radicular low back pain. J Emerg Med. 2006;31(4):365–70.
Goforth HW, Preud’homme XA, Krystal AD. A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain. Sleep. 2014;37(6):1053–60.
Gordon A, Callaghan D, Spink D, Cloutier C, Dzongowski P, O’Mahony W, et al. 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(5):844–60.
Gordon A, Rashiq S, Moulin DE, Clark AJ, Beaulieu AD, Eisenhoffer J, et al. Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. Pain Res Manag. 2010;15(3):169–78.
Innes G, Croskerry P, Worthington J, Beveridge R, Jones D. Ketorolac versus acetaminophen-codeine in the emergency department treatment of acute low back pain. J Emerg Med. 1998;16(4):549–56.
Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, Robertson S. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Curr Med Res Opin. 2012;28(5):847–57.
Thurel C, Bardin T, Boccard E. Analgesic efficacy of an association of 500-mg paracetamol plus 30-mg codeine versus 400-mg paracetamol plus 30-mg dextropropoxyphene in repeated doses for chronic lower back pain. Curr Ther Res Clin Exp. 1991;50(4):463–73.
O’Donnell JB, Ekman EF, Spalding WM, Bhadra P, McCabe D, Berger MF. The effectiveness of a weak opioid medication versus a cyclo-oxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug in treating flare-up of chronic low-back pain: results from two randomized, double-blind, 6-week studies. J Int Med Res. 2009;37(6):1789–802.
Friedman BW, Cisewski D, Irizarry E, Davitt M, Solorzano C, Nassery A, et al. A randomized, double-blind, placebo-controlled trial of naproxen with or without orphenadrine or methocarbamol for acute low back pain. Ann Emerg Med. 2018;71(3):348-56. e5.
Friedman BW, Irizarry E, Chertoff A, Feliciano C, Solorzano C, Zias E, et al. Ibuprofen plus acetaminophen versus ibuprofen alone for acute low back pain: an emergency department–based randomized study. Acad Emerg Med. 2020;27(3):229–35.
Friedman BW, Irizarry E, Solorzano C, Khankel N, Zapata J, Zias E, et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med. 2017;70(2):169-76. e1.
Friedman BW, Irizarry E, Solorzano C, Zias E, Pearlman S, Wollowitz A, et al. A randomized, placebo-controlled trial of ibuprofen plus metaxalone, tizanidine, or baclofen for acute low back pain. Ann Emerg Med. 2019;74(4):512–20.
