NCT03554018

Ibuprofen With or Without Acetaminophen for Low Back Pain

Completed Phase 3 Results posted Last updated 28 February 2024

What this trial tests

Phase 3 trial testing Acetaminophen in Low Back Pain in 120 participants. Completed in 30 September 2019.

Timeline

16 October 2018

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	16 October 2018
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Acetaminophen (Paracetamol) — full drug profile →
• Ibuprofen 600 mg — full drug profile →
• Educational intervention
• Placebo oral capsule

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Montefiore Medical Center

Who can join

Adults 18 to 69, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire Primary · 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

Group	Value	95% CI
Ibuprofen and Acetaminophen	11.1	± 10.7
Ibuprofen and Placebo	11.9	± 9.7

Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale Secondary · 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.

Group	Value	95% CI
Ibuprofen and Acetaminophen	16
Ibuprofen and Placebo	15

Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. Secondary · 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.

Group	Value	95% CI
Ibuprofen and Acetaminophen	36
Ibuprofen and Placebo	32

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ibuprofen and Acetaminophen

Serious: 0/60 (0%)

Deaths: 0/60

Ibuprofen and Placebo

Serious: 0/60 (0%)

Deaths: 0/60

Other adverse events (2 terms — click to expand)

Reaction	System	Ibuprofen and Acetaminophen	Ibuprofen and Placebo
Diarrhea	Gastrointestinal disorders	—	—
Drowsiness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03554018 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.