NCT05851976

Duloxetine for LBP

Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.

Detailed description

Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.

Conditions

• Back Pain, Low

Interventions

Type	Name	Description
DRUG	Naproxen	Naproxen 500mg twice daily for 16 days
DRUG	Duloxetine	Duloxetine 60mg daily for 14 days

Timeline

• Start date: 2023-10-04
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-05-10
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study