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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600mg every 6 hours
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Montefiore Medical Center
The Bronx, New York, United States
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
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.
Time frame: Baseline and one week after discharge from emergency department
Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
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.
Time frame: 7 days after discharge from emergency department
Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.
Time frame: 7 days after discharge from emergency department
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To match acetaminophen, patients will take one or two capsules every 6 hours