NCT03068897

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-05-03
• Primary completion: 2018-07-11
• Completion: 2018-10-11
• First posted: 2017-03-03
• Last updated: 2020-08-12
• Results posted: 2020-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study