Clinical trial NCT05851976: Duloxetine for LBP
Official title: Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Back Pain, Low
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.

Detailed description: Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.

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

Primary outcomes:
measure: Number of participants with moderate or severe Low Back Pain (LBP)
timeFrame: 16 days, 42 days and 84 days after ED discharge
Secondary outcomes:
measure: Number of Participants experiencing LBP based on the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge
measure: Frequency of LBP
timeFrame: 9 days, 16 days, 23 days, and 42 days after ED discharge
measure: Number of visits to a healthcare provider
timeFrame: 9 days, 16 days, 23 days, and 42 days after ED discharge
measure: The number of patients experiencing Depressive Symptoms
timeFrame: 9 days, 16 days, 23 days, and 42 days after ED discharge
measure: The number of patients reporting Satisfaction with treatment
timeFrame: 9 days, 16 days, 23 days, and 42 days after ED discharge
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References: