RECRUITING

Duloxetine for LBP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-04

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05851976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Benjamin Friedman

CONTACT

7189206626

befriedm@montefiore.org

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-04

Study Completion Date2026-05

Study Record Updates

Study Start Date2023-10-04

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Back Pain, Low