NCT03861611

A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.

A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)

Detailed description

More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.

Conditions

• Back Pain Without Radiation
• Low Back Pain

Interventions

Type	Name	Description
DRUG	Ketorolac	Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
DRUG	Ibuprofen	Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
DRUG	Diclofenac	Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
BEHAVIORAL	Educational Intervention	Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Timeline

• Start date: 2019-07-12
• Primary completion: 2021-02-02
• Completion: 2021-02-02
• First posted: 2019-03-04
• Last updated: 2022-05-31
• Results posted: 2022-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study