Ibuprofen With or Without Acetaminophen for Low Back Pain

Phase 3

Completed

Conditions: Low Back Pain

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

Registration Number: NCT03554018

Lead Sponsor: Montefiore Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Ibuprofen 600 mg	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.
Acetaminophen	Acetaminophen	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.
Acetaminophen	Educational intervention	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.
Placebo	Ibuprofen 600 mg	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Placebo	Educational intervention	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Placebo	Placebo oral capsule	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.

Primary Outcome Measures

Name	Time	Method
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire	Baseline and one week after discharge from emergency department	The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale	7 days after discharge from emergency department	Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.	7 days after discharge from emergency department	Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.