Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations

Esther T. Maas; Johanna M. van Dongen; Johan N.S. Juch; J. George Groeneweg; Jan Willem Kallewaard; Michiel R. de Boer; Bart Koes; Arianne P. Verhagen; Frank J.P.M. Huygen; Maurits W. van Tulder; Raymond W.J.G. Ostelo

doi:10.1016/j.jclinepi.2019.09.006

Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations

Esther T. Maas^*, Johanna M. van Dongen, Johan N.S. Juch, J. George Groeneweg, Jan Willem Kallewaard, Michiel R. de Boer, Bart Koes, Arianne P. Verhagen, Frank J.P.M. Huygen, Maurits W. van Tulder, Raymond W.J.G. Ostelo

^*Corresponding author for this work

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Abstract

OBJECTIVE: This study compares participants in RCTs (the MinT-trials) to participants in a related observational study with regards to their low back pain (LBP) symptom course.

DESIGN: & 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 (RF) denervation and an exercise programme. Randomised 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 fulfil at least one of the RCT eligibility criteria (observational group 2). Outcomes were pain intensity, treatment success, and functional status over a three-month period. Longitudinal mixed-model analyses and linear regression models were applied to analyse 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 (OR 0.67; 95%CI 0.50-0.90), and less improvement in physical functioning (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 low back pain should be further explored.

Original language	English
Pages (from-to)	122-132
Number of pages	11
Journal	Journal of Clinical Epidemiology
Volume	116
Early online date	16 Sept 2019
DOIs	https://doi.org/10.1016/j.jclinepi.2019.09.006
Publication status	Published - Dec 2019

Funding

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.

Funders	Funder number
Dutch Society for Anaesthesiology
Dutch health insurance companies
ZonMw	171202013

Keywords

Clinical practice
Low back pain
Observational study
Radiofrequency denervation
Randomized controlled trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Maas, E. T., van Dongen, J. M., Juch, J. N. S., Groeneweg, J. G., Kallewaard, J. W., de Boer, M. R., Koes, B., Verhagen, A. P., Huygen, F. J. P. M., van Tulder, M. W., & Ostelo, R. W. J. G. (2019). Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations. Journal of Clinical Epidemiology, 116, 122-132. https://doi.org/10.1016/j.jclinepi.2019.09.006

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abstract = "OBJECTIVE: This study compares participants in RCTs (the MinT-trials) to participants in a related observational study with regards to their low back pain (LBP) symptom course.DESIGN: & 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 (RF) denervation and an exercise programme. Randomised 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 fulfil at least one of the RCT eligibility criteria (observational group 2). Outcomes were pain intensity, treatment success, and functional status over a three-month period. Longitudinal mixed-model analyses and linear regression models were applied to analyse 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 (OR 0.67; 95%CI 0.50-0.90), and less improvement in physical functioning (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 low back pain should be further explored.",

keywords = "Clinical practice, Low back pain, Observational study, Radiofrequency denervation, Randomized controlled trial",

author = "Maas, {Esther T.} and {van Dongen}, {Johanna M.} and Juch, {Johan N.S.} and Groeneweg, {J. George} and Kallewaard, {Jan Willem} and {de Boer}, {Michiel R.} and Bart Koes and Verhagen, {Arianne P.} and Huygen, {Frank J.P.M.} and {van Tulder}, {Maurits W.} and Ostelo, {Raymond W.J.G.}",

year = "2019",

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Maas, ET , van Dongen, JM, Juch, JNS, Groeneweg, JG, Kallewaard, JW, de Boer, MR, Koes, B, Verhagen, AP, Huygen, FJPM, van Tulder, MW & Ostelo, RWJG 2019, 'Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations', Journal of Clinical Epidemiology, vol. 116, pp. 122-132. https://doi.org/10.1016/j.jclinepi.2019.09.006

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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.

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N2 - OBJECTIVE: This study compares participants in RCTs (the MinT-trials) to participants in a related observational study with regards to their low back pain (LBP) symptom course.DESIGN: & 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 (RF) denervation and an exercise programme. Randomised 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 fulfil at least one of the RCT eligibility criteria (observational group 2). Outcomes were pain intensity, treatment success, and functional status over a three-month period. Longitudinal mixed-model analyses and linear regression models were applied to analyse 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 (OR 0.67; 95%CI 0.50-0.90), and less improvement in physical functioning (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 low back pain should be further explored.

AB - OBJECTIVE: This study compares participants in RCTs (the MinT-trials) to participants in a related observational study with regards to their low back pain (LBP) symptom course.DESIGN: & 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 (RF) denervation and an exercise programme. Randomised 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 fulfil at least one of the RCT eligibility criteria (observational group 2). Outcomes were pain intensity, treatment success, and functional status over a three-month period. Longitudinal mixed-model analyses and linear regression models were applied to analyse 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 (OR 0.67; 95%CI 0.50-0.90), and less improvement in physical functioning (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 low back pain should be further explored.

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KW - Observational study

KW - Radiofrequency denervation

KW - Randomized controlled trial

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Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations

Abstract

Funding

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UN SDGs

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