Using duloxetine to improve low back pain

Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study

This study is testing if the medication duloxetine can help people with low back pain feel better when other treatments haven't worked.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Montefiore Medical Center (other)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT05851976 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 who present to the Emergency Department with non-traumatic, non-radicular musculoskeletal low back pain.

Not a fit: Patients with non-musculoskeletal causes of low back pain or those who are hospitalized will not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new treatment option for patients suffering from low back pain, potentially reducing the duration and severity of their symptoms.

How similar studies have performed: While duloxetine has been studied for various pain conditions, this specific application for acute low back pain is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

The Bronx, New York

• 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

Conditions: Back Pain, Low