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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Back Pain Without Radiation; Low Back Pain

Treatments: Drug: Ibuprofen; Drug: Ketorolac; Drug: Diclofenac; Behavioral: Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03861611

2019-10026

Details and patient eligibility

About

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)

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women age 18-64.
• Present to ED primary for management of Low Back Pain (LBP)
• Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
• Musculoskeletal etiology of low back.
• Non-radicular pain.
• Pain duration <2 weeks (336 hours).
• Non-traumatic LBP
• Participant is to be discharged home.

Exclusion criteria

• Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
• Not available for follow-up
• Pregnant
• Chronic pain syndrome
• Allergic to or intolerant of investigational medications
• Contra-indications to investigational medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 3 patient groups

Ketorolac + Educational Intervention

Experimental group

Description:

Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Treatment:

Drug: Ketorolac

Behavioral: Educational Intervention

Ibuprofen + Educational Intervention

Experimental group

Description:

Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Treatment:

Drug: Ibuprofen

Behavioral: Educational Intervention

Diclofenac + Educational Intervention

Experimental group

Description:

Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Treatment:

Drug: Diclofenac

Behavioral: Educational Intervention