Back pain study aims to match patients to the right treatment
NCT ID NCT04870957
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study with 494 participants looked at how different treatments for chronic low back pain work and who benefits most. Participants first tried an online pain management program, then those who didn't improve much were randomly assigned to mindfulness, physical therapy, acupressure, or duloxetine. The goal was to understand the underlying mechanisms of pain and identify which treatments work best for different people.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors match chronic low back pain patients to the most effective treatment for their specific pain type.
- What could go wrong
- This is a completed study focused on understanding mechanisms, not testing a new treatment. Results may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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494 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Light Phenotyping (all participants): * Definition of cLBP described in the NIH Task Force Report on Research Standards for Chronic Low Back Pain (for example (i.e.), low back pain present at least six months, and present more than half of those days. * Individuals must have the eligible protocol pain interference score on PROMIS Pain Interference. * Individuals must be willing to be randomized to receive any of the four proposed treatments. Exclusion Criteria for Light Phenotyping (all participants): * History of discitis osteomyelitis (spine infection) or spine tumor * History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus * History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength \<4/5 on manual motor testing) * Diagnosis of any vertebral fracture in the last 6 months * Osteoporosis requiring treatment other than vitamin D and calcium supplements * Cancer (History of any bone-related cancer or cancer that metastasized to the bone, Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months, History of any cancer treatment in the last 24 months) * Life expectancy less than 2 years * Unable to speak and write English * Visual or hearing difficulties that would preclude participation * Presence of any history that would preclude scanning in magnetic resonance imaging (MRI) * Uncontrolled drug/alcohol addiction * Individuals receiving disability or compensation within the past year, or involved in litigation * Pregnancy or breastfeeding * History of allergy to duloxetine * Individuals on high doses of opioids (over 100 oral morphine equivalents (OME) per day) * Scheduled back surgery, back surgery within the last year, or more than one back surgery in the past. * Expecting to receive an injection of surgical procedure within the next year for their cLBP * 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. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction Contraindications to Study Intervention: duloxetine * certain medications (per protocol) * renal dysfunction (creatinine clearance \<30 milliliters per minute (mL/min) or End- Stage Renal Failure) * Hepatic dysfunction: Liver function tests (LFTs) elevated times 1.5 Contraindications to Study Intervention: Acupressure * Currently receiving acupressure or acupuncture through formal therapy Contraindications to Study Intervention: MBSR * Current participation in a structured MBSR program Contraindications to Study Intervention: PT \& Exercise * Currently receiving any type of structured manual therapy or exercise treatment for low-back pain. * Contraindication for manual therapy and/or participation in an exercise program Inclusion Criteria for Deep Phenotyping (subset 160 participants): * Right hand dominant (such as the hand used when writing or throwing/catching a ball) * Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing * No contraindications to MRI (i.e., metal implants) * Willingness to refrain from taking any "as needed" medications, including pain medications such as Nonsteroidal anti-inflammatory drugs (i.e., Motrin, Advil, Aleve), acetaminophen, and opioids, for 8 hours before undergoing neuroimaging and 10.1 Quantitative Sensory Testing (QST) * Willingness to refrain from alcohol and nicotine on the day of QST and neuroimaging (alcohol and nicotine consumption is allowed after testing is completed) * Willingness to refrain from any unusual physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable) * Able to lie still on back for 2 hours during MRI Exclusion Criteria for Deep Phenotyping (subset 160 participants): * Severe claustrophobia precluding MRI and evoked pain testing during scanning * Diagnosed peripheral neuropathy * Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail) * Body Mass Index greater than 45 or unable to comfortably fit in the bore of the MRI magnet
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48170, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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