Duloxetine for LBP

Last updated: November 19, 2024
Sponsor: Montefiore Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Treatment

Duloxetine

Naproxen

Clinical Study ID

NCT05851976
2023-14971
  • Ages 18-64
  • All Genders

Study 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.

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:

  1. history of hypersensitivity to NSAIDs or aspirin

  2. active or history of peptic ulcer disease, chronic dyspepsia, or active orhistory 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 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

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Duloxetine
Phase: 4
Study Start date:
October 04, 2023
Estimated Completion Date:
May 31, 2026

Study Description

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

Connect with a study center

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.