At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 320 enrolled

Drug / intervention

Metaxalone +4 moredrug

Likely dose

Ibuprofen 600 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03068897

NCT03068897Phase 4Completed

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Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial

Montefiore Medical Center·interventional·Posted Mar 3, 2017·Updated Aug 12, 2020

In Brief

A Phase 4 clinical trial evaluating Metaxalone, Tizanidine, and 3 other interventions for Low Back Pain. Completed, enrolled 320 participants across 1 site.

Detailed Summary

This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLow Back Pain

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

2017201820192020202120222023202420252026

First PostedMar 2017

Enrollment StartMay 2017

Primary CompletionJul 2018

Study CompletionOct 2018

TodayJul 2026

First PostedMar 3, 2017

Enrollment StartMay 3, 2017

Primary CompletionJul 11, 2018

Study CompletionOct 11, 2018

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 9.3 years ago

Interventions

Metaxalonedrug

Metaxalone 400-800mg

Tizanidinedrug

Tizanidine 2-4mg

Baclofendrug

Baclofen 10-20mg

Ibuprofen 600 mgdrug

Ibuprofen

Educational interventionbehavioral

Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.