NCT02665286

Orphenadrine and Methocarbamol for LBP

Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

Detailed description

Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Orphenadrine	Orphenadrine 100mg PO BID x 7 days
DRUG	Methocarbamol	Methocarbamol 750mg 1-2 tabs po TID x 7 days
DRUG	Naproxen	Naproxen 500mg PO BID x 7 days
DRUG	Placebo	1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2016-01-27
• Last updated: 2018-06-26
• Results posted: 2018-06-26

Locations

1 site across 1 country: United States