Efficacy of paracetamol, diclofenac and advice for acute low back pain in general practice: design of a randomized controlled trial (PACE Plus)

BMC Musculoskeletal Disorders

Study Protocol

D. Rizopoulos¹  Y. D. M. Van Trier²  P. A. J. Luijsterburg²  M. Schreijenberg²  B. W. Koes²  M. A. Koopmanschap³  L. Voogt⁴  C. G. Maher⁵ 

[1] Department of Biostatistics, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands;Department of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Health Policy and Management/iMTA, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, The Netherlands;Dutch Association for Back pain Patients ‘The Spine’, Bentinckstraat 21, Lichtenvoorde, The Netherlands;The George Institute for Global Health, University of Sydney, PO Box M201, 2050, Sydney, NSW, Australia;

关键词: Low back pain;    Therapy;    General practitioners;    General practice;    Pain;    Analgesics;    Acetaminophen;    Anti-inflammatory agents;    Non-steroidal;    Diclofenac;    Randomized controlled trial;    Clinical trial;   

DOI  :  10.1186/s12891-017-1432-5

 received in 2017-01-17, accepted in 2017-01-26,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundLow back pain is common and associated with a considerable burden to patients and society. There is uncertainty regarding the relative benefit of paracetamol and diclofenac and regarding the additional effect of pain medication compared with advice only in patients with acute low back pain. This trial will assess the effectiveness of paracetamol, diclofenac and placebo for acute low back pain over a period of 4 weeks. Furthermore, this trial will assess the additional effectiveness of paracetamol, diclofenac and placebo compared with advice only for acute low back pain over a period of 4 weeks.MethodsThe PACE Plus trial is a multi-center, placebo-blinded, superiority randomized controlled trial in primary care, with a follow-up of 12 weeks. Patients with acute low back pain aged 18–60 years presenting in general practice will be included.Patients are randomized into four groups: 1) Advice only (usual care conforming with the clinical guideline of the Dutch College of General Practitioners); 2) Advice and paracetamol; 3) Advice and diclofenac; 4) Advice and placebo. The primary outcome is low back pain intensity measured with a numerical rating scale (0–10). Secondary outcomes include compliance to treatment, disability, perceived recovery, costs, adverse reactions, satisfaction, sleep quality, co-interventions and adequacy of blinding.Between group differences for low back pain intensity will be evaluated using a repeated measurements analysis with linear effects models. An economic evaluation will be performed using a cost-effectiveness analysis with low back pain intensity and a cost-utility analysis with quality of life. Explorative analyses will be performed to assess effect modification by predefined variables.Ethical approval has been granted. Trial results will be released to an appropriate peer-viewed journal.DiscussionThis paper presents the design of the PACE Plus trial: a multi-center, placebo-blinded, superiority randomized controlled trial in primary care that will assess the effectiveness of advice only, paracetamol, diclofenac and placebo for acute low back pain.Trial registrationDutch Trial Registration NTR6089, registered September 14th, 2016. Protocol: Version 4, June 2016.

【 授权许可】

CC BY   
© The Author(s). 2017