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Completed

NCT Number: NCT03554018

Ibuprofen With or Without Acetaminophen for Low Back Pain

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.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Acetaminophen 500-1000mg every 6 hours

Ibuprofen 600 mg

Drug

Ibuprofen 600mg every 6 hours

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)

Placebo oral capsule

Drug

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

Primary outcomes

  1. Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire

    Time frame: 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 interval values have been verified by staff statisticians.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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