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Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

NCT03068897 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2020-08-12

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

DRUG

Metaxalone

Metaxalone 400-800mg

DRUG

Tizanidine

Tizanidine 2-4mg

DRUG

Baclofen

Baclofen 10-20mg

DRUG

Ibuprofen 600 mg

Ibuprofen

BEHAVIORAL

Educational intervention

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2018-07-11
Completion
2018-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068897 on ClinicalTrials.gov