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Duloxetine for LBP

Primary Purpose

Back Pain, Low

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen
Duloxetine
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain, Low

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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: history of hypersensitivity to NSAIDs or aspirin active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed Severe heart failure (NYHA 2 or worse) uncontrolled blood pressure (>160/100) Glomerular Filtration Rate (GFR_ <60ml/min Current use of anti-coagulants cirrhosis or acute hepatitis Contra-indication to duloxetine: alcohol use disorder chronic liver disease chronic kidney disease glaucoma Active use of medication for depression Score >4 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naproxen + duloxetine

Naproxen + placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with Moderate or severe pain
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.
Number of participants with Moderate or severe pain
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous 24 hours.
Number of participants with Moderate or severe pain
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.

Secondary Outcome Measures

Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results
This 24-item lower back pain (LBP) functional scale is recommended for use in LBP research. Items are scored 0 if left blank or 1 if endorsed, for a total Roland Morris score ranging from 0-24. Higher scores represent higher levels of pain-related disability.

Full Information

First Posted
May 1, 2023
Last Updated
September 18, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05851976
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naproxen + duloxetine
Arm Type
Experimental
Arm Title
Naproxen + placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500mg twice daily for 16 days
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine 60mg daily for 14 days
Primary Outcome Measure Information:
Title
Number of participants with Moderate or severe pain
Description
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.
Time Frame
6 weeks
Title
Number of participants with Moderate or severe pain
Description
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous 24 hours.
Time Frame
16 days
Title
Number of participants with Moderate or severe pain
Description
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results
Description
This 24-item lower back pain (LBP) functional scale is recommended for use in LBP research. Items are scored 0 if left blank or 1 if endorsed, for a total Roland Morris score ranging from 0-24. Higher scores represent higher levels of pain-related disability.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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: history of hypersensitivity to NSAIDs or aspirin active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed Severe heart failure (NYHA 2 or worse) uncontrolled blood pressure (>160/100) Glomerular Filtration Rate (GFR_ <60ml/min Current use of anti-coagulants cirrhosis or acute hepatitis Contra-indication to duloxetine: alcohol use disorder chronic liver disease chronic kidney disease glaucoma Active use of medication for depression Score >4 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Friedman
Phone
7189206626
Email
befriedm@montefiore.org
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Duloxetine for LBP

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