Phase
Condition
Chronic Pain
Radiculopathy
Treatment
Ibuprofen 400 mg
Dexamethasone Oral
Educational Intervention
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Present to ED primarily for management of acute radicular LBP, defined as pain orparesthesia originating from the lower back and radiating to the buttock and or legin a radicular pattern. Some patients may not have prominent LBP but a radicularsymptom--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 increasedrisk of adverse medication effects in older adults.
Pain duration <2 week
Prior to the acute attack of radicular LBP, back pain cannot occur more frequentlythan half of the days in the last 3 months. Patients with more frequent backpain/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 theprevious month
Functionally impairing radicular LBP: A baseline score of > 5 on the Roland-MorrisDisability Questionnaire
Exclusion
Exclusion Criteria:
Not available for follow-up
Pregnant
Chronic pain syndrome defined as use of any analgesic medication on a daily ornear-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 ofanti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2xthe upper limit of normal)
Study Design
Connect with a study center
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
Bronx, New York 10461
United StatesActive - Recruiting
Montefiore Medical Center - Moses ED
Bronx, New York 10467
United StatesActive - Recruiting
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