CompletedNot Applicable

Optimize Low Back Pain

United States749 participantsStarted 2019-03-22

Plain-language summary

The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Oswestry Disability Index From Baseline to 10 Weeks

Timeframe: baseline, 10 weeks

Change in Oswestry Disability Index From 10-weeks to 52 Weeks

Timeframe: 10 weeks, 52 weeks

Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks

Timeframe: baseline, 10 weeks

Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks

Timeframe: 10 weeks, 52 weeks

Trial details

NCT IDNCT03859713

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

Results submitted2025-08-02

View on ClinicalTrials.gov More Low Back Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Oswestry Disability Index From Baseline to 10 Weeks

Timeframe: baseline, 10 weeks

Change in Oswestry Disability Index From 10-weeks to 52 Weeks

Timeframe: 10 weeks, 52 weeks

Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks

Timeframe: baseline, 10 weeks

Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks

Timeframe: 10 weeks, 52 weeks