Ibuprofen 400 mg
DrugIbuprofen 400 mg PO every 8 hours as needed for 7 days
NCT Number: NCT05721027
This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 4
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED, The Bronx, New York, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ibuprofen 400 mg PO every 8 hours as needed for 7 days
Dexamethasone 16 mg PO during ED visit and next day
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Time frame: 2 days (48 hours)
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)
Time frame: 2 days and 7 days after ED discharge
Worst Radicular LBP pain incurred over the previous 24 hours will be assessed at 2 days and 7 days after ED discharge using a four point ordinal scale: Severe, Moderate, Mild, or None
Time frame: 2 days and 7 days after ED discharge
Frequency of Radicular LBP is evaluated at 2 days and 7 days after ED discharge based on a five point Likert scale: Not at all, Rarely, Sometimes, Usually, and Always
Time frame: 2 days and 7 days after ED discharge
Administration of any analgesic or LBP medication (Yes or No) within the previous 24 hours will be assessed at 2 days and 7 days after ED discharge
Time frame: 2 days and 7 days after ED discharge
The Absolute RMDQ score will be tabulated at 2 days and 7 days after ED discharge. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability
Time frame: 2 days and 7 days after ED discharge
The patient will be evaluated for the ability to return to all usual activities at 2 days and 7 days after ED discharge based on a binary (Yes/No) response
Time frame: 2 days and 7 days after ED discharge
The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge
Time frame: 2 days and 7 days after ED discharge
Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
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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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