Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain: a randomized clinical trial

Adrian C. Traeger, Hopin Lee, Marcus Hubscher, Ian W. Skinner, G. Lorimer Moseley, Michael K. Nicholas, Nicholas Henschke, Kathryn M. Refshauge, Fiona M. Blyth, Chris J. Main, Julia M. Hush, Serigne Lo, James H. McAuley

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.

Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain.

Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks’ duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education.

Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).

Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.

Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, –0.3 [95% CI, –1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, –1.6 points on a 24-point scale [95% CI, –3.1 to –0.1]) and 3 months (mean difference, –1.7 points, [95% CI, –3.2 to –0.2]) but not at 6 or 12 months.

Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.

Trial Registration: Australian Clinical Trial Registration Number: 12612001180808
LanguageEnglish
Pages161-169
Number of pages9
JournalJAMA Neurology
Volume76
Issue number2
Early online date5 Nov 2018
DOIs
Publication statusPublished - 1 Feb 2019

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Patient Education
Low Back Pain
Randomized Controlled Trials
Placebos
Pain
Self Care
Chronic Pain
General Practice
Analgesia
Primary Health Care
Patient Care
Research Personnel
Outcome Assessment (Health Care)
Clinical Trials
Guidelines

Keywords

  • pain education
  • Low back pain

Cite this

Traeger, A. C., Lee, H., Hubscher, M., Skinner, I. W., Moseley, G. L., Nicholas, M. K., ... McAuley, J. H. (2019). Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain: a randomized clinical trial. JAMA Neurology, 76(2), 161-169. https://doi.org/10.1001/jamaneurol.2018.3376
Traeger, Adrian C. ; Lee, Hopin ; Hubscher, Marcus ; Skinner, Ian W. ; Moseley, G. Lorimer ; Nicholas, Michael K. ; Henschke, Nicholas ; Refshauge, Kathryn M. ; Blyth, Fiona M. ; Main, Chris J. ; Hush, Julia M. ; Lo, Serigne ; McAuley, James H. / Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain : a randomized clinical trial. In: JAMA Neurology. 2019 ; Vol. 76, No. 2. pp. 161-169.
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abstract = "Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain.Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks’ duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education.Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0{\%}) were female. Retention rates were greater than 90{\%} at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, –0.3 [95{\%} CI, –1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, –1.6 points on a 24-point scale [95{\%} CI, –3.1 to –0.1]) and 3 months (mean difference, –1.7 points, [95{\%} CI, –3.2 to –0.2]) but not at 6 or 12 months.Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.Trial Registration: Australian Clinical Trial Registration Number: 12612001180808",
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Traeger, AC, Lee, H, Hubscher, M, Skinner, IW, Moseley, GL, Nicholas, MK, Henschke, N, Refshauge, KM, Blyth, FM, Main, CJ, Hush, JM, Lo, S & McAuley, JH 2019, 'Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain: a randomized clinical trial', JAMA Neurology, vol. 76, no. 2, pp. 161-169. https://doi.org/10.1001/jamaneurol.2018.3376

Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain : a randomized clinical trial. / Traeger, Adrian C.; Lee, Hopin; Hubscher, Marcus; Skinner, Ian W.; Moseley, G. Lorimer; Nicholas, Michael K.; Henschke, Nicholas; Refshauge, Kathryn M.; Blyth, Fiona M.; Main, Chris J.; Hush, Julia M.; Lo, Serigne; McAuley, James H.

In: JAMA Neurology, Vol. 76, No. 2, 01.02.2019, p. 161-169.

Research output: Contribution to journalArticleResearchpeer-review

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N2 - Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain.Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks’ duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education.Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, –0.3 [95% CI, –1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, –1.6 points on a 24-point scale [95% CI, –3.1 to –0.1]) and 3 months (mean difference, –1.7 points, [95% CI, –3.2 to –0.2]) but not at 6 or 12 months.Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.Trial Registration: Australian Clinical Trial Registration Number: 12612001180808

AB - Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain.Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks’ duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education.Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, –0.3 [95% CI, –1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, –1.6 points on a 24-point scale [95% CI, –3.1 to –0.1]) and 3 months (mean difference, –1.7 points, [95% CI, –3.2 to –0.2]) but not at 6 or 12 months.Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.Trial Registration: Australian Clinical Trial Registration Number: 12612001180808

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