BridgeMD
New treatment option for Back Pain, Low
Official title Duloxetine for LBP
ClinicalTrials.gov ID: NCT05851976
What this study is testing
What is Naproxen?
Naproxen is an investigational medicine, given as an once-daily, being studied as a potential treatment for back pain, low.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the...
- Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like...
- Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not...
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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:
- 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 \> 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...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.