Trial · NCT01587274

A Randomized Study of Three Medication Regimens for Acute Low Back Pain

NCT01587274, Phase 4, Completed, Montefiore Medical Center; results first posted 2018-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized Study of Three Medication Regimens for Acute Low Back Pain. Trials, record NCT01587274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01587274

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized Study of Three Medication Regimens for Acute Low Back Pain
NCT number: NCT01587274
Status: Completed
Phases: Phase 4
Enrollment: 323 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Acute Low Back Pain
Interventions: Naproxen, Cyclobenzaprine, Oxycodone/ acetaminophen
First posted: 2012-04-30
Last updated: 2018-07-31
Results first posted: 2018-07-31

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	Baseline and one week after discharge from emergency department	The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	Baseline and one week after discharge from emergency department	Multiple imputation used to account for participants lost to follow-up	units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	Opioid	5	Inter-Quartile Range 0 to 15	units on a scale
Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	Skeletal Muscle Relaxant	4	Inter-Quartile Range 0 to 16	units on a scale
Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	Naproxen Alone	7	Inter-Quartile Range 0 to 18	units on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Opioid	108
Overall Study	STARTED	Skeletal Muscle Relaxant	108
Overall Study	STARTED	Naproxen Alone	107
Overall Study	COMPLETED	Opioid	104
Overall Study	COMPLETED	Skeletal Muscle Relaxant	103
Overall Study	COMPLETED	Naproxen Alone	104
Overall Study	NOT COMPLETED	Opioid	4
Overall Study	NOT COMPLETED	Skeletal Muscle Relaxant	5
Overall Study	NOT COMPLETED	Naproxen Alone	3

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea/ vomiting	Gastrointestinal disorders	Opioid	19	108
other	Nausea/ vomiting	Gastrointestinal disorders	Skeletal Muscle Relaxant	4	108
other	Nausea/ vomiting	Gastrointestinal disorders	Naproxen Alone	6	107
other	Drowsiness	Nervous system disorders	Opioid	16	108
other	Drowsiness	Nervous system disorders	Skeletal Muscle Relaxant	7	108
other	Drowsiness	Nervous system disorders	Naproxen Alone	4	107
other	Dizziness	Nervous system disorders	Opioid	16	108
other	Dizziness	Nervous system disorders	Skeletal Muscle Relaxant	7	108
other	Dizziness	Nervous system disorders	Naproxen Alone	4	107
other	Stomach irritation	Gastrointestinal disorders	Opioid	7	108

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Opioid
Total, all-cause mortality	Skeletal Muscle Relaxant
Total, all-cause mortality	Naproxen Alone
Total, other adverse events	Opioid	43	108
Total, other adverse events	Skeletal Muscle Relaxant	36	108
Total, other adverse events	Naproxen Alone	22	107
Total, serious adverse events	Opioid	0	108
Total, serious adverse events	Skeletal Muscle Relaxant	0	108
Total, serious adverse events	Naproxen Alone	0	107

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26501533	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01587274

GET https://conductscience.org/api/trials/v1/NCT01587274/registered

API reference For AI assistants