Ibuprofen With or Without Acetaminophen for Low Back Pain

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Acetaminophen; Behavioral: Educational intervention; Drug: Placebo oral capsule; Drug: Ibuprofen 600 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03554018

2018-9182

Details and patient eligibility

About

This is a randomized clinical trial comparing two interventions for acute low back pain:

1. Ibuprofen + acetaminophen
2. Ibuprofen + placebo

Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.

Enrollment: 120 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.

• Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.
• Patient is to be discharged home.
• Age 18-69
• Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
• Pain duration <2 weeks (336 hours).
• Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.
• Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
• Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion criteria

• Not available for follow-up
• Pregnant
• Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
• Allergic to or intolerant of investigational medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Acetaminophen

Experimental group

Description:

Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.

Treatment:

Drug: Acetaminophen

Behavioral: Educational intervention

Drug: Ibuprofen 600 mg

Placebo

Active Comparator group

Description:

Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.

Treatment:

Behavioral: Educational intervention

Drug: Ibuprofen 600 mg

Drug: Placebo oral capsule