Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
Patient is to be discharged home.
Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
Pain duration <2 week
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ibuprofen 400 mg
DrugIbuprofen 400 mg PO every 8 hours as needed for 7 days
Dexamethasone Oral
DrugDexamethasone 16 mg PO during ED visit and next day
Educational Intervention
BehavioralResearch 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
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Ibuprofen + dexamethasone + educational interventionExperimental treatment 3 interventions
Group B: Ibuprofen + placebo + educational interventionPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Roland Morris Disability Questionnaire (RMDQ) score
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 (48 hours)Secondary outcomes
1
Worst Radicular LBP
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 discharge2
Frequency of Radicular LBP
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 discharge3
Analgesic or LBP medication within the previous 24 hours
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 discharge4
Absolute Roland Morris Disability Questionnaire (RMDQ) score
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 dischargeSponsors and contacts
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Source ClinicalTrials.gov