New combo tackles chronic pain without opioids
NCT ID NCT04395001
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether combining a non-opioid pain medication (duloxetine) with an online pain-coping skills program helps people with long-term muscle and joint pain. 280 adults with daily pain for at least 3 months took part. The goal was to see if this approach reduces pain severity and improves physical function better than either treatment alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- duloxetine (a non-opioid pain medication) and web-based cognitive behavioral therapy (pain-coping skills training)
- What this could lead to
- If successful, this combination could offer a more effective, non-opioid way to manage chronic pain and improve daily function.
- What could go wrong
- This is a Phase 4 study, so the drugs are already approved, but the combination may not prove significantly better than either alone. Side effects from duloxetine (e.g., increased blood pressure) are possible.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
280 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Jul 2024
- Lead sponsor
-
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
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
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: * patients at the primary care clinic with daily pain for 3 months or longer affecting the low back, neck, hip, knee or widespread pain; * at least moderate in BPI global pain severity Exclusion Criteria: * uncontrolled hypertension (because duloxetine rarely increases blood pressure) * active suicidal ideation * planned elective surgery during the study period (to avoid the confounding effect of possible complicated post-surgery recovery course on the primary outcome) * ongoing unresolved disability claims * inflammatory arthritis (e.g., lupus and ankylosing spondylitis) * cancer-related musculoskeletal pain * pregnancy * history of bipolar disorder or schizophrenia * narrow angle glaucoma * severe renal impairment (creatinine clearance \<30) * current use of duloxetine * current use of any of the following medications (to avoid adverse drug-to-drug interactions): tricyclic antidepressant \> 25 mg daily dose, monoamine oxidase inhibitors, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, venlafaxine, milnacipran, mirtazapine, gabapentin or aripiprazole, serotonin precursors (e.g., tryptophan), and strong CYP1A2 inhibitors (e.g., ciprofloxacin, other fluoroquinolones, fluvoxamine and verapamil)
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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
-
Wake Forest Baptist Health Department of Rheumatology
Winston-Salem, North Carolina, 27157, United States
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