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Talking away the pain: CBT may stop chronic pain after broken bones

NCT ID NCT04274530

Symptom relief Sponsor: McMaster University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether cognitive behavioral therapy (CBT) can reduce persistent pain after fracture surgery. Over 1,000 adults with broken arm or leg bones received either CBT or usual care. The goal was to see if CBT lowers the number of people who still have moderate to severe pain a year after their injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy (CBT)
What this could lead to
If it works, CBT could become a standard, drug-free way to lower the risk of chronic pain after fracture surgery.
What could go wrong
This is a completed trial, but CBT may not work for everyone, and results depend on patient willingness and ability to engage in therapy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,024 people

The number who actually took part.

Started

Jan 2021

Finished

Aug 2025

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 years and older

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: * Adult men or women aged 18 years and older. * Presenting to fracture clinic within 2-12 weeks following an acute open or closed fracture of the appendicular skeleton. Patients with multiple fractures may be included. * Fracture treated operatively with internal fixation. * Willing to participate in CBT. * Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel). * Consistent access to a smart phone and/or tablet that is capable of running the CBT provider's application. * Provision of informed consent. Exclusion Criteria: * Fragility fracture. * Stress fracture. * Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture. * Among patients who are fully weightbearing, those not experiencing any pain in the fracture region. * Active psychosis. * Active suicidality. * Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the trial. * Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months). * Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up. * Incarceration. * Currently enrolled in a study that does not permit co-enrolment in other trials. * Previously enrolled in the COPE trial. * Other reason to exclude the patient, as approved by the Methods Centre.

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Conditions

The condition(s) this trial relates to.

Acute Pain bone fracture Chronic Pain chronic pain syndrome Fractures, Closed Fractures, Open Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fractures, closed Fractures, open Pain, acute Pain, chronic Pain, postoperative

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Centre

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Centre

    Lebanon, New Hampshire, 03766, United States

  • Hamilton Health Sciences - General Site

    Hamilton, Ontario, L8L 2X2, Canada

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • Memorial University Newfoundland

    St. John's, Newfoundland and Labrador, Canada

  • Ottawa Civic Hospital

    Ottawa, Ontario, Canada

  • PRISMA Health

    Greenwood, South Carolina, 29615, United States

  • University of Calgary - Foothills Hospital

    Calgary, Alberta, Canada

  • University of Maryland - Capital Region Medical Center

    Largo, Maryland, 20774, United States

  • University of Maryland - R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.