Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: A randomized clinical trial

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Abstract

Importance Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination. Objective To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen. Design, Setting, and Participants This randomized, double-blind, 3-group studywas conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014. Interventions All participants were given 20 tablets of naproxen, 500mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5mg; or oxycodone, 5mg/acetaminophen, 325mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Main Outcomes and Measures The primary outcomewas improvement in RMDQ between ED discharge and 1 week later. Results Demographic characteristicswere comparable among the 3 groups.At baseline, medianRMDQscore in the placebo groupwas 20(interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20(IQR,17- 22).At 1-week follow-up, the meanRMDQimprovementwas 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in meanRMDQimprovement for cyclobenzaprine vs placebowas0.3 (98.3%CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3%CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine,0.9 (98.3%CI, -2.1 to 3.9; P = .45). Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.

Original languageEnglish (US)
Pages (from-to)1572-1580
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume314
Issue number15
DOIs
StatePublished - Oct 20 2015

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Naproxen
Low Back Pain
Randomized Controlled Trials
Placebos
Hospital Emergency Service
Tablets
Neuromuscular Agents
Pain
cyclobenzaprine
oxycodone-acetaminophen
Acetaminophen
Opioid Analgesics
Anti-Inflammatory Agents
Demography
Outcome Assessment (Health Care)
Surveys and Questionnaires

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{cd256d1b121243ec8e5a2a0a051b1b10,
title = "Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: A randomized clinical trial",
abstract = "Importance Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination. Objective To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen. Design, Setting, and Participants This randomized, double-blind, 3-group studywas conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014. Interventions All participants were given 20 tablets of naproxen, 500mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5mg; or oxycodone, 5mg/acetaminophen, 325mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Main Outcomes and Measures The primary outcomewas improvement in RMDQ between ED discharge and 1 week later. Results Demographic characteristicswere comparable among the 3 groups.At baseline, medianRMDQscore in the placebo groupwas 20(interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20(IQR,17- 22).At 1-week follow-up, the meanRMDQimprovementwas 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in meanRMDQimprovement for cyclobenzaprine vs placebowas0.3 (98.3{\%}CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3{\%}CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine,0.9 (98.3{\%}CI, -2.1 to 3.9; P = .45). Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.",
author = "Friedman, {Benjamin W.} and Dym, {Andrew A.} and Davitt, {Michelle M.} and Holden, {Lynne M.} and Clemencia Solorzano and David Esses and Bijur, {Polly E.} and Gallagher, {E. John}",
year = "2015",
month = "10",
day = "20",
doi = "10.1001/jama.2015.13043",
language = "English (US)",
volume = "314",
pages = "1572--1580",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "15",

}

TY - JOUR

T1 - Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain

T2 - A randomized clinical trial

AU - Friedman, Benjamin W.

AU - Dym, Andrew A.

AU - Davitt, Michelle M.

AU - Holden, Lynne M.

AU - Solorzano, Clemencia

AU - Esses, David

AU - Bijur, Polly E.

AU - Gallagher, E. John

PY - 2015/10/20

Y1 - 2015/10/20

N2 - Importance Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination. Objective To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen. Design, Setting, and Participants This randomized, double-blind, 3-group studywas conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014. Interventions All participants were given 20 tablets of naproxen, 500mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5mg; or oxycodone, 5mg/acetaminophen, 325mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Main Outcomes and Measures The primary outcomewas improvement in RMDQ between ED discharge and 1 week later. Results Demographic characteristicswere comparable among the 3 groups.At baseline, medianRMDQscore in the placebo groupwas 20(interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20(IQR,17- 22).At 1-week follow-up, the meanRMDQimprovementwas 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in meanRMDQimprovement for cyclobenzaprine vs placebowas0.3 (98.3%CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3%CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine,0.9 (98.3%CI, -2.1 to 3.9; P = .45). Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.

AB - Importance Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination. Objective To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen. Design, Setting, and Participants This randomized, double-blind, 3-group studywas conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014. Interventions All participants were given 20 tablets of naproxen, 500mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5mg; or oxycodone, 5mg/acetaminophen, 325mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Main Outcomes and Measures The primary outcomewas improvement in RMDQ between ED discharge and 1 week later. Results Demographic characteristicswere comparable among the 3 groups.At baseline, medianRMDQscore in the placebo groupwas 20(interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20(IQR,17- 22).At 1-week follow-up, the meanRMDQimprovementwas 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in meanRMDQimprovement for cyclobenzaprine vs placebowas0.3 (98.3%CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3%CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine,0.9 (98.3%CI, -2.1 to 3.9; P = .45). Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.

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U2 - 10.1001/jama.2015.13043

DO - 10.1001/jama.2015.13043

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JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 15

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