Consumer focused education on paracetamol side effects, inadequate outcomes and weaning for individuals with low back pain: protocol for a feasibility study
Background: Prescription and over the counter medications, such as paracetamol, account for a significant proportion of the direct and indirect costs in managing low back pain (LBP). Existing research has not only questioned the efficacy of paracetamol use for musculoskeletal conditions such as LBP, but also its safety. No previous study has investigated the feasibility of a pharmacological education tool for individuals using paracetamol to manage their LBP. The aims of this study are to investigate: (1) the acceptability and experience of participants with the pharmacological education tool, (2) feasibility of recruitment, data collection and outcome measure completion, and (3) participant’s willingness to participate in a randomised control trial.
Methods: This will be a single group repeated measures study design recruiting individuals from community organisations. Included participants will be over 18 years, experiencing acute, chronic or recurrent episodes of LBP and self-report consumption of paracetamol for pain relief weekly for at least one month. This study will be open for recruitment from June 2021 to August 2021.
Conclusions: Our findings will inform the feasibility of conducting a larger randomised controlled trial. This study will be judged as feasible to proceed to a full trial based if, 1) recruitment sources are each able to enrol at least 20 participants into the study within three months of initial advertisement, 2) the majority of participants find the study and intervention experience as acceptable, and 3) there is less than 20% of missing data for the primary outcomes, and a minimum of 85% follow-up rate for enrolled participants.
James SL. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2013;2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789-858.
Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP et al. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018;6736:1-16.
Martin LM, Larssen G, McDonald K, Briggs G, Whitfort A, Brooks T et al, A problem worth solving. Arthritis Osteoporosis Victoria. 2013;1-8.
Walker BF, Muller R, Grant WD. Low back pain in Australian adults: the economic burden. Asia-Pacific J Public Health. 2003;15:79-87.
Becker A, Held H, Redaelli M, Strauch K, Chenot JF et al. Low back pain in primary care: costs of care and prediction of future health care utilization. Spine. 1976;35:1714-20.
Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine. 1976;37:E668-77.
Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Erratum appears in Ann Intern Med. 2008;5;148(3):247-8.
Summaries for patients. Diagnosis and treatment of low back pain: recommendations from the American College of Physicians/American Pain Society. Ann Intern Med. 2007;147(7):I45;
Almeida M, Saragiotto B, Richards B, Maher CG. Primary care management of non-specific low back pain: key messages from recent clinical guidelines. Med j Australia. 2010;208:272-5.
Machado GC, Maher CG, Ferreira PH, Pinheiro MB, Chung-Wei CL, Day RO. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ. 2015;350:h1225.
Schreijenberg M. Inferential reproduction analysis demonstrated that "paracetamol for acute low back pain" trial conclusions were reproducible. J Clin Epidemiol. 2020;121:45-54.
Chou R, Deyo R, Friedly J, Skelly A, Weimer M, Fu R et al. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann internal med. 2017;166:480-92.
Yabuki S, Kuen AK, Tam CK, Murakami T, Ushida T, Wang JH et al. Evidence-Based Recommendations on the Pharmacological Management of Osteoarthritis and Chronic Low Back Pain: An Asian Consensus. Asian j anesthesiol. 2019;57(2):37-54.
Shaheed C, Ferreira GE, Dmitritchenko A, McLachlan AJ, Day RO, Saragiotto B et al. The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews. Med J Australia. 2021;214(7):324-31.
Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CW, Chenot JF et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018;27(11):2791-803.
Mishriky J, Stupans I, Chan V. The role of the pharmacist in low back pain management: a narrative review of practice guidelines on paracetamol vs non-steroidal anti-inflammatory drugs. Pharm Pract (Granada). 2020;18:2075.
Wilk V, Palmer HD, Stosic RG, McLachlan AJ. Evidence and practice in the self-management of low back pain: findings from an Australian internet-based survey. Clin j pain. 2010;26:533-40.
Larson AM. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42:1364-72.
Sistanizad M, Peterson GM. Drug-induced liver injury in the Australian setting. J Clin Pharm Ther. 2013;38:115-209.
Cairns R et al. Paracetamol poisoning-related hospital admissions and deaths in Australia, 2004-2017. Med J Aust. 2019;211:218-23.
Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a Pharmacist-Led Educational Intervention on Inappropriate Medication Prescriptions in Older Adults: The D-PRESCRIBE Randomized Clinical Trial. Jama 320, 1889-1898, (2018).
Martin, P., Tamblyn, R., Ahmed, S. & Tannenbaum, C. A drug education tool developed for older adults changes knowledge, beliefs and risk perceptions about inappropriate benzodiazepine prescriptions in the elderly. Patient Educ Couns. 2013;92:81-7.
Mohammed AN. An observational study of paracetamol (acetaminophen) deprescribing in patients with cancer pain receiving opioids for moderate-to-severe pain. 2017;11.
Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995;14:1933-40.
Thabane L. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1,
Michie S, Van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.
Michie S. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46:81-95.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Informatics. 2009;42:377-81.
Belanger L, Morin CM, Bastien C, Ladouceur R. Self-efficacy and compliance with benzodiazepine taper in older adults with chronic insomnia. Health Psychol. 2005;24:281-7.
Bandura, A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37:122-47.
Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol health. 1999;14:1-24.
Bolton JE, Humphreys BK, Van Hede HJA. Validity of weekly recall ratings of average pain intensity in neck pain patients. J Manipulative Physiol Ther. 2010;33:612-7.
Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. Development and validation of the patients' attitudes towards deprescribing (PATD) questionnaire. Int J Clin Pharm. 2013;35:51-6.
Elander J. Development and validation of a short-form Pain Medication Attitudes Questionnaire (PMAQ-14). Pain. 2017;158:400-7.
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67-74.
Pengel LH, Refshauge KM, Maher CG. Responsiveness of pain, disability, and physical impairment outcomes in patients with low back pain. Spine. 2004;29:879-83.
Martin P, Tannenbaum C. A realist evaluation of patients’ decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017;7:e015959.