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Back pain study tests best combo of therapy and mindfulness

NCT ID NCT03859713

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different treatment sequences for chronic low back pain in 749 adults. Participants first received either physical therapy or cognitive behavioral therapy. Those who didn't improve were switched to the other therapy or added mindfulness. The goal was to find which approach best reduces pain and improves daily function over a year.

What this could mean

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

Active substance
Physical therapy, cognitive behavioral therapy, and mindfulness
What this could lead to
If successful, this could show which treatment or combination works best for chronic low back pain, helping doctors personalize care.
What could go wrong
This is a completed study comparing existing treatments, not a new breakthrough. Results may not apply to everyone with back pain.

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

749 people

The number who actually took part.

Started

Mar 2019

Finished

Oct 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 64 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: * Age 18 - 64 years at the time of enrollment. * Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP. * Healthcare visit for LBP in the past 90 days. * At least moderate levels of pain and disability requiring ODI score \>24 and pain intensity rating \> 4. * Has access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits. Exclusion Criteria: * Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc. * Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc. * Knowingly pregnant * Has received physical therapy for LBP; or CBT or mindfulness for any reason with a provider in prior 90 days * Currently receiving substance use disorder treatment * Any lumbar spine surgery in the past year.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome Low Back Pain

As listed by the trial registrant

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

Contacts and locations

Locations

  • Intermountain Health Care

    Salt Lake City, Utah, 84107, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • The University of Utah Healthcare System

    Salt Lake City, Utah, 84108, United States

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