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New combo tackles chronic pain without opioids

NCT ID NCT04395001

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Feb 2021

Finished

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

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

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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