Chronic Low-back Pain study: Duloxetine
Official title Algorithm-informed Decision-making to Advance Pain Treatment
ClinicalTrials.gov ID: NCT07731750
What this study is testing
What is Duloxetine?
Duloxetine is an investigational medicine, being studied as a potential treatment for chronic low-back pain.
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
- The study wants to find out how accurately the algorithm can pick effective pain treatments based on a person’s symptoms, health history, and lifestyle.
- Who it's for
- Adults who have chronic low‑back pain.
- What's involved
- You will give information about your pain, medical history, and daily habits, and the algorithm will generate treatment recommendations. No new medication or procedure is given.
- Time commitment: about 8 weeks
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- Participants must meet the definition of Chronic Low Back Pain (cLBP) described in the NIH Task Force Report on Research Standards for cLBP, i.e...
- Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is 50.
- Individuals must be willing and eligible to receive at least three of the four proposed interventions.
- Able to stand for at least 10 minutes
You likely can't join if
- Red flags suggesting the presence of an identifiable cause of low back pain, including fever, weight loss, initiation of pain following major trauma...
- Unable to read, write of speak fluent English
- Visual or hearing difficulties that would preclude participation
- Active uncontrolled drug/alcohol addiction
- Individuals receiving new disability or compensation or involved in litigation in the past 12 months.
- Pregnancy or breastfeeding
See the full eligibility criteria
- Participants must meet the definition of Chronic Low Back Pain (cLBP) described in the NIH Task Force Report on Research Standards for cLBP, i.e., low back pain present at least six months, and present more than half of...
- Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is 50.
- Individuals must be willing and eligible to receive at least three of the four proposed interventions.
- Able to stand for at least 10 minutes
- Red flags suggesting the presence of an identifiable cause of low back pain, including fever, weight loss, initiation of pain following major trauma, immunosuppression, IV drug use, recent bacterial infection, severe or...
- Unable to read, write of speak fluent English
- Visual or hearing difficulties that would preclude participation
- Active uncontrolled drug/alcohol addiction
- Individuals receiving new disability or compensation or involved in litigation in the past 12 months.
- Pregnancy or breastfeeding
- Individuals on high doses of opioids (over 100 Oral Morphine Equivalents [OME] per day).
- Upcoming scheduled back surgery, back surgery within the last year, or more than one back surgery in the past.
- History of discitis osteomyelitis (spine infection) or spine tumor
- History of an autoimmune disorder such as ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
- History of cauda equina syndrome or spinal radiculopathy
- Diagnosis of schizophrenia or schizoaffective diagnosis
- Diagnosis of any vertebral fracture in the last 6 months
- Osteoporosis requiring treatment (vitamin D and calcium supplements are acceptable)
- Cancer
- History of any bone-related cancer or cancer that metastasized to the bone
- Currently in treatment for cancer or plan to start cancer treatment in the next 12 months
- History of any cancer treatment in the last 24 months
- Life expectancy is less than 2 years
- Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.