Ibuprofen With or Without Acetaminophen for Low Back Pain

NCT03554018 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2018-9182
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.Ibuprofen + acetaminophen
2. 2.Ibuprofen + placebo

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and one week after discharge from emergency department

Secondary Outcomes (2)

• Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale

  7 days after discharge from emergency department

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

  7 days after discharge from emergency department

Study Arms (2)

Acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention

Placebo

ACTIVE COMPARATOR

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

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

Interventions

Acetaminophen DRUG

Acetaminophen 500-1000mg every 6 hours

Acetaminophen

Ibuprofen 600 mg DRUG

Ibuprofen 600mg every 6 hours

Acetaminophen; Placebo

Educational intervention BEHAVIORAL

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)

Acetaminophen; Placebo

Placebo oral capsule DRUG

To match acetaminophen, patients will take one or two capsules every 6 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen; Ibuprofen; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Benjamin Friedman
• Organization: Montefiore

befriedm@montefiore.org

718-920-6626

Study Officials

• Benjamin W Friedman, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 12, 2018
• Study Start: October 16, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 28, 2024
• Results First Posted: September 22, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)