Phase 3
N=120
Ibuprofen With or Without Acetaminophen for Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03554018 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire — 11.1; 11.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Acetaminophen (Drug); Ibuprofen 600 mg (Drug); Educational intervention (Behavioral); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire |
11.1; 11.9 | — |
| SECONDARY Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale |
16; 15 | — |
| SECONDARY Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. |
36; 32 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03554018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.