TY - JOUR
T1 - Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations
AU - Maas, Esther T.
AU - van Dongen, Johanna M.
AU - Juch, Johan N.S.
AU - Groeneweg, J. George
AU - Kallewaard, Jan Willem
AU - de Boer, Michiel R.
AU - Koes, Bart
AU - Verhagen, Arianne P.
AU - Huygen, Frank J.P.M.
AU - van Tulder, Maurits W.
AU - Ostelo, Raymond W.J.G.
N1 - Funding Information:
The authors thank the Netherlands Organisation for Health Research and Development ( 171202013 ), the Dutch Society for Anaesthesiology, and the Dutch health insurance companies for funding this study. The authors thank Sie Pei Lim for her assistance in the data cleaning. The authors would also like to thank all patients, physiotherapists, and everyone working on the MinT study at one of the participating pain clinics.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/12
Y1 - 2019/12
N2 - 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.
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.
KW - Clinical practice
KW - Low back pain
KW - Observational study
KW - Radiofrequency denervation
KW - Randomized controlled trial
U2 - 10.1016/j.jclinepi.2019.09.006
DO - 10.1016/j.jclinepi.2019.09.006
M3 - Article
C2 - 31536786
AN - SCOPUS:85073037704
SN - 0895-4356
VL - 116
SP - 122
EP - 132
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -