Ibuprofen With or Without Acetaminophen for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554018
• Other study ID #: 2018-9182
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Acetaminophen
Acetaminophen 500-1000mg every 6 hours
• Ibuprofen 600 mg
Ibuprofen 600mg every 6 hours

Behavioral:
• Educational intervention
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)

Drug:
• Placebo oral capsule
To match acetaminophen, patients will take one or two capsules every 6 hours

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	7 days after discharge from emergency department
Secondary	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.	7 days after discharge from emergency department