Recruiting NCT05721027
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ibuprofen 400 mg, Dexamethasone Oral, Educational Intervention.
- Who it may be relevant to
- Registry conditions: Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Ibuprofen 400 mg
Ibuprofen 400 mg PO every 8 hours as needed for 7 days - Drug Dexamethasone Oral
Dexamethasone 16 mg PO during ED visit and next day - Behavioral Educational Intervention
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
Primary outcome measures
- Change in Roland Morris Disability Questionnaire (RMDQ) score [Time frame: 2 days (48 hours)]
Secondary outcome measures (7)
- Worst Radicular LBP [Time frame: 2 days and 7 days after ED discharge]
- Frequency of Radicular LBP [Time frame: 2 days and 7 days after ED discharge]
- Analgesic or LBP medication within the previous 24 hours [Time frame: 2 days and 7 days after ED discharge]
- Absolute Roland Morris Disability Questionnaire (RMDQ) score [Time frame: 2 days and 7 days after ED discharge]
- Return to all usual activities [Time frame: 2 days and 7 days after ED discharge]
- Number of visits to any healthcare provider [Time frame: 2 days and 7 days after ED discharge]
- Satisfaction with Treatment [Time frame: 2 days and 7 days after ED discharge]
Eligibility criteria
Inclusion criteria
- 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
- Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
- Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
- Functionally impairing radicular LBP: 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
- Chronic steroid use
- Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED — The Bronx
- Montefiore Medical Center - Moses ED — The Bronx
Identifiers
NCT: NCT05721027 · 2023-14723