Low Back PainOPTIMIZENCT03859713

Optimize Low Back Pain

A study testing Physical Therapy, Cognitive Behavioral Therapy and Mindfulness in people with Low Back Pain and Chronic Pain, run by University of Utah at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Low Back Pain, Chronic Pain
What is being tested?: Physical Therapy, Cognitive Behavioral Therapy and Mindfulness
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 749 participants
Where: 3 sitesUnited States
Study dates: 22 Mar 2019to 1 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johns Hopkins University
Baltimore, Maryland, 21287
Intermountain Health Care
Salt Lake City, Utah, 84107
The University of Utah Healthcare System
Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

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.

Read the detailed description

The study uses a sequential multiple randomization (SMART) design. The study will compare the effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to complete treatment. At the 10-week assessment researchers will examine if the patient has responded to initial treatment using a patient-centered, validated definition of successful response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are responders to initial treatment will receive up to 2 additional sessions of the same treatment to assist transition to self-management. Non-responders will be re-randomized to a second treatment strategy of either switching to the other initial treatment (i.e., patients receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also 8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment.

The study has two co-primary outcomes; function and pain. The investigators will use the ODI, a well-validated, reliable and responsive patient-reported measure of LBP-related function recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings are made for current, worst and best pain over the past 24 hours with an average computed to represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work and healthcare utilization.

Conditions: Low Back Pain, Chronic Pain
Being tested: Physical Therapy, Cognitive Behavioral Therapy, Mindfulness, Phase I Treatment, Phase II Switching
Keywords: Physical Therapy, Cognitive Behavioral Therapy, Mindfulness, Adaptive Treatment Regimens
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical TherapyBehavioural
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
Cognitive Behavioral TherapyBehavioural
Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
MindfulnessBehavioural
Also called Mindfulness-Oriented Recovery Enhancement
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
Phase I TreatmentBehavioural
Includes all participants receiving any Phase I intervention
Phase II SwitchingBehavioural
Includes all participants receiving Switching as Phase II intervention

Study groups in NCT03859713
Study group	Role	What they receive
PT followed by Switching to CBT in Phase II for nonresponders	Experimental	Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. Receives: Behavioral: Physical Therapy; Behavioral: Cognitive Behavioral Therapy
PT followed by Mindfulness in Phase II for nonresponders	Experimental	Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. Receives: Behavioral: Physical Therapy; Behavioral: Mindfulness
CBT followed by Switching to PT in Phase II for nonresponders	Experimental	Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. Receives: Behavioral: Physical Therapy; Behavioral: Cognitive Behavioral Therapy
CBT followed by Mindfulness in Phase II for nonresponders	Experimental	Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. Receives: Behavioral: Cognitive Behavioral Therapy; Behavioral: Mindfulness
Phase I PT Treatment	Active comparator	This arm includes participants assigned to PT as their Phase I treatment Receives: Behavioral: Physical Therapy
Phase I CBT Treatment	Active comparator	This arm includes participants assigned to CBT for their Phase I treatment Receives: Behavioral: Cognitive Behavioral Therapy
Phase II Switching Treatment	Active comparator	Includes all Non-Responders in Phase I who were re-randomized to Switch in Phase II Receives: Behavioral: Phase I Treatment; Behavioral: Phase II Switching
Phase II Mindfulness Treatment	Active comparator	Include all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II Receives: Behavioral: Mindfulness; Behavioral: Phase I Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Oswestry Disability Index From Baseline to 10 Weeks
Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
Measured: baseline, 10 weeks
Change in Oswestry Disability Index From 10-weeks to 52 Weeks
Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability
Measured: 10 weeks, 52 weeks
Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity.
Measured: baseline, 10 weeks
Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity.
Measured: 10 weeks, 52 weeks

Secondary outcomes (13)

Health-related Quality of Life
PROMIS-29 subscales scores reported across 7 domains
Measured: baseline, 10 weeks, 26 weeks, 52 weeks
Change in Pain Interference From Baseline to 10 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference.
Measured: baseline, 10 weeks
Change in Fatigue From Baseline to !0 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue.
Measured: baseline, 10 weeks
Change in Sleep Disturbance From Baseline to 10 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance
Measured: baseline, 10 weeks
Change in Anxiety From Baseline to 10 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety
Measured: baseline, 10 weeks
Change in Depression From Baseline to 10 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression
Measured: baseline, 10 weeks
Change in Social Role Participation From Baseline to 10 Weeks
Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles
Measured: baseline, 10 weeks
Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks
Use of either MRI or CT for low back pain
Measured: baseline, 10 weeks
Opioid Utilization at 10-week Assessment
Long-term use of opioids for pain management defined as use on all or most days in the past 90 days
Measured: baseline, 10 weeks
Treatment Side Effects
Self-reported physical or psychological side effects of study treatments
Measured: 10 weeks
Treatment Responder
Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score
Measured: baseline, 10 weeks
Health Care Utilization of Injections for Back Pain Over 10 Weeks
Use of injections for low back pain
Measured: baseline, 10 weeks
Health Care Utilization of Radiographs for Back Pain Over 10 Weeks
Use of radiographs for low back pain
Measured: baseline, 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20191 Oct 2024

First posted1 Mar 2019
Study start22 Mar 2019
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 749 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859713
Sponsor's protocol ID: 00116150
Acronym: OPTIMIZE
Status last verified: Feb 2026
First submitted: 26 Feb 2019
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z.
PubMed 32393216
Fritz JM, Skolasky RL, Brennan G, Minick K, Wegener ST, Lane E, Garland EL, Aaron RV, Bardsley T, Fino N, Zhang Y, Shen J, Conroy MB, Hunter S, Hanley A, Thackeray A, Rassu FS, McLaughlin K, Cook D, Greene T. Effectiveness of Nonpharmacologic Treatments for Chronic Low Back Pain : A Sequential, Multiple-Assignment, Randomized Trial. Ann Intern Med. 2026 Jun;179(6):773-784. doi: 10.7326/ANNALS-25-04645. Epub 2026 Apr 21.
PubMed 42008809
Fritz JM, Greene T, Brennan GP, Minick K, Lane E, Wegener ST, Skolasky RL. Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME). Trials. 2023 Feb 23;24(1):137. doi: 10.1186/s13063-023-07150-1.
PubMed 36823645
Fritz JM, Lane E, Minick KI, Bardsley T, Brennan G, Hunter SJ, McGee T, Rassu FS, Wegener ST, Skolasky RL. Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. Telemed Rep. 2021 Nov 3;2(1):258-263. doi: 10.1089/tmr.2021.0028. eCollection 2021.
PubMed 34927165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
ClinicalTrials.gov ID: NCT03859713
Acronym / sponsor ID: OPTIMIZE / 00116150
Conditions: Low Back Pain, Chronic Pain
Keywords: Physical Therapy, Cognitive Behavioral Therapy, Mindfulness, Adaptive Treatment Regimens
Study type: Interventional
Recruitment status: Completed
Enrolment: 749 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 22 Mar 2019 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 1 Mar 2019 (actual)
Results: Posted 6 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 8
Model description: Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.

Arm	Type	Receives
PT followed by Switching to CBT in Phase II for nonresponders	Experimental	Behavioral: Physical Therapy, Behavioral: Cognitive Behavioral TherapyPhase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
PT followed by Mindfulness in Phase II for nonresponders	Experimental	Behavioral: Physical Therapy, Behavioral: MindfulnessPhase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
CBT followed by Switching to PT in Phase II for nonresponders	Experimental	Behavioral: Physical Therapy, Behavioral: Cognitive Behavioral TherapyPhase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
CBT followed by Mindfulness in Phase II for nonresponders	Experimental	Behavioral: Cognitive Behavioral Therapy, Behavioral: MindfulnessPhase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
Phase I PT Treatment	Active comparator	Behavioral: Physical TherapyThis arm includes participants assigned to PT as their Phase I treatment
Phase I CBT Treatment	Active comparator	Behavioral: Cognitive Behavioral TherapyThis arm includes participants assigned to CBT for their Phase I treatment
Phase II Switching Treatment	Active comparator	Behavioral: Phase I Treatment, Behavioral: Phase II SwitchingIncludes all Non-Responders in Phase I who were re-randomized to Switch in Phase II
Phase II Mindfulness Treatment	Active comparator	Behavioral: Mindfulness, Behavioral: Phase I TreatmentInclude all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical TherapyEvidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.	Behavioural	CBT followed by Switching to PT in Phase II for nonresponders, PT followed by Mindfulness in Phase II for nonresponders, PT followed by Switching to CBT in Phase II for nonresponders, Phase I PT Treatment
Cognitive Behavioral TherapyEvidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction	Behavioural	CBT followed by Mindfulness in Phase II for nonresponders, CBT followed by Switching to PT in Phase II for nonresponders, PT followed by Switching to CBT in Phase II for nonresponders, Phase I CBT Treatment
MindfulnessAlso: Mindfulness-Oriented Recovery EnhancementMindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.	Behavioural	CBT followed by Mindfulness in Phase II for nonresponders, PT followed by Mindfulness in Phase II for nonresponders, Phase II Mindfulness Treatment
Phase I TreatmentIncludes all participants receiving any Phase I intervention	Behavioural	Phase II Mindfulness Treatment, Phase II Switching Treatment
Phase II SwitchingIncludes all participants receiving Switching as Phase II intervention	Behavioural	Phase II Switching Treatment

Primary outcome

Change in Oswestry Disability Index From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
Change in Oswestry Disability Index From 10-weeks to 52 Weeks
Time frame: 10 weeks, 52 weeks
Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability
Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity.
Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks
Time frame: 10 weeks, 52 weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity.

13 secondary outcomes

Health-related Quality of Life
Time frame: baseline, 10 weeks, 26 weeks, 52 weeks
Change in Pain Interference From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Change in Fatigue From Baseline to !0 Weeks
Time frame: baseline, 10 weeks
Change in Sleep Disturbance From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Change in Anxiety From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Change in Depression From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Change in Social Role Participation From Baseline to 10 Weeks
Time frame: baseline, 10 weeks
Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks
Time frame: baseline, 10 weeks
Opioid Utilization at 10-week Assessment
Time frame: baseline, 10 weeks
Treatment Side Effects
Time frame: 10 weeks
Treatment Responder
Time frame: baseline, 10 weeks
Health Care Utilization of Injections for Back Pain Over 10 Weeks
Time frame: baseline, 10 weeks
Health Care Utilization of Radiographs for Back Pain Over 10 Weeks
Time frame: baseline, 10 weeks

Results and safety

Results posted to the registry on 6 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PT Followed by Switching to CBT in Phase II for Nonresponders	0	0
PT Followed by Mindfulness in Phase II for Nonresponders	0	0
CBT Followed by Switching to PT in Phase II for Nonresponders	0	0
CBT Followed by Mindfulness in Phase II for Nonresponders	0	0
Responder: Phase I PT Treatment Alone	374	296
Responder: Phase I CBT Treatment Alone	375	280

Primary outcome: Change in Oswestry Disability Index From Baseline to 10 Weeks

Time frame: baseline, 10 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Phase I PT Treatment Alone n = 374	Phase I CBT Treatment Alone n = 375
Value	-8.8 (0.81)	-6.1 (0.80)

Phase I PT Treatment Alone vs Phase I CBT Treatment Alone: Mean Difference (Net): 2.8 (96% CI 0.38 to 5.1), p = 0.02, Constrained longitudinal model

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

Time frame: 10 weeks, 52 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Phase I Non-Responders Assigned to Switching in Phase II n = 213	Phase I Non-Responders Assigned to Mindfulness in Phase II n = 210
Value	-5.4 (0.96)	-4.9 (0.97)

Phase I Non-Responders Assigned to Switching in Phase II vs Phase I Non-Responders Assigned to Mindfulness in Phase II: Mean Difference (Net): 0.43 (96% CI -0.29 to 2.4), p = 0.76, Mixed Models Analysis

Population analysed: Note that as specified in the study protocol and statistical analysis plan, non-responders randomized to swtich treatments or to mindfulness are combined across Phase I treatment groups.

Primary outcome: Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks

Time frame: baseline, 10 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Phase I PT Treatment Alone n = 374	Phase I CBT Treatment Alone n = 375
Value	-1.2 (0.11)	-0.84 (0.11)

Phase I PT Treatment Alone vs Phase I CBT Treatment Alone: Mean Difference (Net): 0.32 (99% CI -0.07 to 0.71), p = 0.03, Mixed Models Analysis

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

Time frame: 10 weeks, 52 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Phase I Non-Responders Assigned to Switching in Phase II n = 213	Phase I Non-Responders Assigned to Mindfulness in Phase II n = 210
Value	-0.53 (0.15)	-0.48 (.15)

Phase I Non-Responders Assigned to Switching in Phase II vs Phase I Non-Responders Assigned to Mindfulness in Phase II: Mean Difference (Net): -0.05 (99% CI -0.58 to 0.48), p = 0.80, Mixed Models Analysis

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I PT Treatment	9 of 374 (2.4%)	0 of 374 (0%)	0 of 374
Phase I CBT Treatment	12 of 375 (3.2%)	0 of 375 (0%)	0 of 375
Phase I Non-Responders Re-Randomized to CBT	2 of 103 (1.9%)	0 of 103 (0%)	0 of 103
Phase I Non-Responders Re-Randomized to PT	3 of 110 (2.7%)	0 of 110 (0%)	0 of 110
Phase I Non-Responders Re-Randomized to Mindfulness	11 of 197 (5.6%)	0 of 197 (0%)	0 of 197

Limitations and caveats (from the sponsor): Our study has limitations. Treatment initiations rates were low, reducing the treatment dose for participants. COVID caused a suspension of enrollment for 13 months, requiring a reduction in the target sample size. While sufficient power was retained for the co-primary aims, the power for some secondary and exploratory aims was impacted. Finally, our study design did not include a treatment as usual condition for comparison with our study treatments and embedded adaptive interventions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32393216Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z.
Derived from this study: PubMed 42008809Fritz JM, Skolasky RL, Brennan G, Minick K, Wegener ST, Lane E, Garland EL, Aaron RV, Bardsley T, Fino N, Zhang Y, Shen J, Conroy MB, Hunter S, Hanley A, Thackeray A, Rassu FS, McLaughlin K, Cook D, Greene T. Effectiveness of Nonpharmacologic Treatments for Chronic Low Back Pain : A Sequential, Multiple-Assignment, Randomized Trial. Ann Intern Med. 2026 Jun;179(6):773-784. doi: 10.7326/ANNALS-25-04645. Epub 2026 Apr 21.
Derived from this study: PubMed 36823645Fritz JM, Greene T, Brennan GP, Minick K, Lane E, Wegener ST, Skolasky RL. Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME). Trials. 2023 Feb 23;24(1):137. doi: 10.1186/s13063-023-07150-1.
Derived from this study: PubMed 34927165Fritz JM, Lane E, Minick KI, Bardsley T, Brennan G, Hunter SJ, McGee T, Rassu FS, Wegener ST, Skolasky RL. Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. Telemed Rep. 2021 Nov 3;2(1):258-263. doi: 10.1089/tmr.2021.0028. eCollection 2021.
Individual participant dataSharing planned: No

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Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
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The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
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Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
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Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie Fritz, PT, PhD principal investigator

University of Utah

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Therapy, Cognitive Behavioral Therapy and Mindfulness in people with Low Back Pain and Chronic Pain, run by University of Utah at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oswestry Disability Index From Baseline to 10 Weeks (time frame: baseline, 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859713, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.