PMID- 31536786 OWN - NLM STAT- MEDLINE DCOM- 20200521 LR - 20200521 IS - 1878-5921 (Electronic) IS - 0895-4356 (Linking) VI - 116 DP - 2019 Dec TI - Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations. PG - 122-132 LID - S0895-4356(19)30375-0 [pii] LID - 10.1016/j.jclinepi.2019.09.006 [doi] AB - OBJECTIVE: This study compares participants in randomized controlled trials (RCTs) (the Minimal Invasive Treatment [MinT] trials) to participants in a related observational study with regard to their low back pain (LBP) symptom course. STUDY DESIGN AND SETTING: Eligible patients were diagnosed with chronic LBP originating from the facet joints (N = 615) or sacroiliac (SI) joints (N = 533) and were treated with radiofrequency denervation and an exercise program. Randomized patients were compared to patients in the related observational study who fulfilled all RCT eligibility criteria (observational group 1) and to patients who did not fulfill at least one of the RCT eligibility criteria (observational group 2). Outcomes were pain intensity, treatment success, and functional status over a 3-month period. Longitudinal mixed-model analyses and linear regression models were applied to analyze the differences in outcomes between the RCT and observational study groups. RESULTS: No differences in symptom course were found between patients in the RCTs and patients in observational group 1. Patients with facet joint pain in observational group 2 had overall less treatment success (odds ratios [OR], 0.67; 95% confidence interval [CI], 0.50-0.90), and less improvement in physical functioning (mean difference [MD], 5.82; 95% CI, 2.54-9.11) compared to the RCT patients. Patients with SI joint pain in observational group 2 had higher pain scores (MD, 0.40; 95% CI, 0.09-0.72), less treatment success (OR, 0.72; 95% CI, 0.54-0.96), and less improvement in physical functioning (MD, 7.16; 95% CI, 3.84-10.47) compared to the RCT patients. CONCLUSION: This supports the generalizability of results from the MinT RCTs as this study suggests that these RCTs reflect clinical practice when comparing similar populations. To what extent this holds true for all RCTs in LBP should be further explored. CI - Copyright (c) 2019 Elsevier Inc. All rights reserved. FAU - Maas, Esther T AU - Maas ET AD - Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Amsterdam Movement Science Research Institute, 1081HV, Amsterdam, the Netherlands. Electronic address: esther.maas@ubc.ca. FAU - van Dongen, Johanna M AU - van Dongen JM AD - Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Amsterdam Movement Science Research Institute, 1081HV, Amsterdam, the Netherlands. FAU - Juch, Johan N S AU - Juch JNS AD - Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, the Netherlands. FAU - Groeneweg, J George AU - Groeneweg JG AD - Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, the Netherlands. FAU - Kallewaard, Jan-Willem AU - Kallewaard JW AD - Department of Anaesthesiology, Rijnstate Hospital, Velp, the Netherlands. FAU - de Boer, Michiel R AU - de Boer MR AD - Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Amsterdam Movement Science Research Institute, 1081HV, Amsterdam, the Netherlands. FAU - Koes, Bart AU - Koes B AD - Department of General Practice, Erasmus Medical Centre, Rotterdam, the Netherlands; Center for Muscle and Joint Health, University of Southern Denmark, Odense, Denmark. FAU - Verhagen, Arianne P AU - Verhagen AP AD - Department of General Practice, Erasmus Medical Centre, Rotterdam, the Netherlands; University of Technology Sydney, Graduate School of Health, Discipline of Physiotherapy, Ultimo, New South Wales, 2007, Australia. FAU - Huygen, Frank J P M AU - Huygen FJPM AD - Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, the Netherlands. FAU - van Tulder, Maurits W AU - van Tulder MW AD - Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Amsterdam Movement Science Research Institute, 1081HV, Amsterdam, the Netherlands; Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark. FAU - Ostelo, Raymond W J G AU - Ostelo RWJG AD - Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Amsterdam Movement Science Research Institute, 1081HV, Amsterdam, the Netherlands; Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. LA - eng SI - NTR/NTR3531 PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190916 PL - United States TA - J Clin Epidemiol JT - Journal of clinical epidemiology JID - 8801383 SB - IM MH - Adult MH - Aged MH - Combined Modality Therapy/*methods MH - Denervation MH - Exercise Therapy MH - Female MH - Humans MH - Linear Models MH - Low Back Pain/*diagnosis/etiology/*therapy MH - Male MH - Middle Aged MH - Observational Studies as Topic MH - Pain Measurement MH - Randomized Controlled Trials as Topic MH - Sacroiliac Joint MH - Treatment Outcome MH - Zygapophyseal Joint OTO - NOTNLM OT - Clinical practice OT - Low back pain OT - Observational study OT - Radiofrequency denervation OT - Randomized controlled trial EDAT- 2019/09/20 06:00 MHDA- 2020/05/22 06:00 CRDT- 2019/09/20 06:00 PHST- 2019/04/28 00:00 [received] PHST- 2019/08/15 00:00 [revised] PHST- 2019/09/10 00:00 [accepted] PHST- 2019/09/20 06:00 [pubmed] PHST- 2020/05/22 06:00 [medline] PHST- 2019/09/20 06:00 [entrez] AID - S0895-4356(19)30375-0 [pii] AID - 10.1016/j.jclinepi.2019.09.006 [doi] PST - ppublish SO - J Clin Epidemiol. 2019 Dec;116:122-132. doi: 10.1016/j.jclinepi.2019.09.006. Epub 2019 Sep 16.