Using duloxetine to improve low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the effectiveness of duloxetine in alleviating low back pain in patients who have not found relief from naproxen after 48 hours. Participants will be recruited from the Emergency Department and must have a diagnosis of non-traumatic, non-radicular musculoskeletal low back pain. The study will compare the outcomes of those receiving duloxetine versus a placebo to determine if duloxetine can help prevent persistent pain after an acute episode.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Present to Emergency Department (ED) primary for management of LBP, defined as pain originating 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 etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
* Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
* Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
* Pain duration \<2 weeks (336 hours).
* Prior to the acute attack of LBP, back pain cannot occur more frequently than once per week.
* Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

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:

  1. history of hypersensitivity to NSAIDs or aspirin
  2. active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
  3. Severe heart failure (NYHA 2 or worse)
  4. uncontrolled blood pressure (\>160/100)
  5. Glomerular Filtration Rate (GFR) \<60ml/min
  6. Current use of anti-coagulants
  7. cirrhosis or acute hepatitis
* Contra-indication to duloxetine:

  1. alcohol use disorder
  2. chronic liver disease
  3. chronic kidney disease
  4. glaucoma
  5. Active use of medication for depression
  6. Score \> 10 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts 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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Benjamin Friedman, MD — Montefiore Medical Center
• Study coordinator: Benjamin Friedman, MD
• Email: befriedm@montefiore.org
• Phone: 718-920-6626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.