Phase
Condition
Chronic Pain
Treatment
Duloxetine
Naproxen
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Present to Emergency Department (ED) primary for management of LBP, defined as painoriginating 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 etiologiessuch as urinary tract infection, ovarian cysts, or influenza like illness will beexcluded. The primary clinical diagnosis, at the conclusion of the ED visit, must bea diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
Patient is to be discharged home. Patients admitted to the hospital are more likelyto be treated with parenteral medication and therefore are not appropriate for thisstudy.
Age 18-64 Enrollment will be limited to adults younger than 65 years because of theincreased risk of adverse medication effects in older patients.
Non-radicular pain. Patients will be excluded if the pain radiates below the glutealfolds in a radicular pattern.
Pain duration <2 weeks (336 hours).
Prior to the acute attack of LBP, back pain cannot occur more frequently than onceper week.
Functionally impairing back pain: A baseline score of > 5 on the Roland-MorrisDisability Questionnaire
Exclusion
Exclusion Criteria:
Not available for follow-up
Pregnant or breast-feeding
Chronic pain syndrome defined as moderate or severe pain anywhere in their body on >= 50% of days for at least three months
Allergic to or intolerant of investigational medications
Contra-indications to non-steroidal anti-inflammatory drugs:
history of hypersensitivity to NSAIDs or aspirin
active or history of peptic ulcer disease, chronic dyspepsia, or active orhistory of gastrointestinal bleed
Severe heart failure (NYHA 2 or worse)
uncontrolled blood pressure (>160/100)
Glomerular Filtration Rate (GFR) <60ml/min
Current use of anti-coagulants
cirrhosis or acute hepatitis
- Contra-indication to duloxetine:
alcohol use disorder
chronic liver disease
chronic kidney disease
glaucoma
Active use of medication for depression
Score > 10 on the Patient Health Questionnaire (PHQ-9) screening instrument orthoughts of suicide, symptoms of feeling down, depressed, or hopeless
PHQ9 score >4. Now we would like to exclude patients with a PHQ9 score >10 or symptoms of feeling down, depressed, or hopeless
Study Design
Study Description
Connect with a study center
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
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