NCT03859713: OPTIMIZE

Optimize Low Back Pain

Completed NA Results posted Last updated 6 March 2026

What this trial tests

NA trial testing Physical Therapy in Low Back Pain in 749 participants. Completed in 1 October 2024.

Timeline

22 March 2019

Primary endpoint
1 October 2024

1 October 2024

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	749
Start date	22 March 2019
Primary completion	1 October 2024
Estimated completion	1 October 2024
Sites	3 locations across United States

Drugs / interventions tested

• Physical Therapy
• Cognitive Behavioral Therapy
• Mindfulness
• Phase I Treatment
• Phase II Switching

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →
• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of Utah

Who can join

Adults 18 to 64, any sex, with Low Back Pain or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Oswestry Disability Index From Baseline to 10 Weeks Primary · 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

Group	Value	95% CI
Phase I PT Treatment Alone	-8.8	± 0.81
Phase I CBT Treatment Alone	-6.1	± 0.80

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

Group	Value	95% CI
Phase I Non-Responders Assigned to Switching in Phase II	-5.4	± 0.96
Phase I Non-Responders Assigned to Mindfulness in Phase II	-4.9	± 0.97

Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks Primary · 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.

Group	Value	95% CI
Phase I PT Treatment Alone	-1.2	± 0.11
Phase I CBT Treatment Alone	-0.84	± 0.11

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

Group	Value	95% CI
Phase I Non-Responders Assigned to Switching in Phase II	-0.53	± 0.15
Phase I Non-Responders Assigned to Mindfulness in Phase II	-0.48	± .15

Change in Pain Interference From Baseline to 10 Weeks Secondary · baseline, 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.

Group	Value	95% CI
Phase I PT Treatment	-4.0	± 0.43
Phase I CBT Treatment	-2.2	± 0.36

Change in Fatigue From Baseline to !0 Weeks Secondary · baseline, 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 greater improvement in fatigue.

Group	Value	95% CI
Phase I PT Treatment	-1.2	± 0.50
Phase I CBT Treatment	0.25	± 0.48

Change in Sleep Disturbance From Baseline to 10 Weeks Secondary · baseline, 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

Group	Value	95% CI
Phase I PT Treatment	-2.1	± 0.40
Phase I CBT Treatment	-0.60	± 0.42

Change in Anxiety From Baseline to 10 Weeks Secondary · baseline, 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

Group	Value	95% CI
Phase I PT Treatment	0.43	± 0.49
Phase I CBT Treatment	2.5	± 0.51

Change in Depression From Baseline to 10 Weeks Secondary · baseline, 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

Group	Value	95% CI
Phase I PT Treatment	1.3	± 0.49
Phase I CBT Treatment	2.0	± 0.47

Change in Social Role Participation From Baseline to 10 Weeks Secondary · baseline, 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

Group	Value	95% CI
Phase I PT Treatment	1.9	± 0.44
Phase I CBT Treatment	0.50	± 0.36

Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks Secondary · baseline, 10 weeks

Use of either MRI or CT for low back pain

Group	Value	95% CI
Phase I PT Treatment	27
Phase I CBT Treatment	30

Opioid Utilization at 10-week Assessment Secondary · baseline, 10 weeks

Long-term use of opioids for pain management defined as use on all or most days in the past 90 days

Group	Value	95% CI
Phase I PT Treatment	32
Phase I CBT Treatment	35

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase I PT Treatment

Serious: 9/374 (2%)

Deaths: 0/374

Phase I CBT Treatment

Serious: 12/375 (3%)

Deaths: 0/375

Phase I Non-Responders Re-Randomized to CBT

Serious: 2/103 (2%)

Deaths: 0/103

Phase I Non-Responders Re-Randomized to PT

Serious: 3/110 (3%)

Deaths: 0/110

Phase I Non-Responders Re-Randomized to Mindfulness

Serious: 11/197 (6%)

Deaths: 0/197

Serious adverse events (10 terms)

Reaction	System	Phase I PT Treatment	Phase I CBT Treatment	Phase I Non-Responders Re-…	Phase I Non-Responders Re-…	Phase I Non-Responders Re-…
Back Surgery	Surgical and medical procedures	—	—	—	—	—
COVID Hospitalization	Infections and infestations	—	—	—	—	—
Musculoskeletal Injury or Fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hopsitalization following accident	Injury, poisoning and procedural complications	—	—	—	—	—
Hospitalized for abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Hospitalized for Chest Pain	Cardiac disorders	—	—	—	—	—
Hopsitalized for Osteomyelitis of humerus	Infections and infestations	—	—	—	—	—
Appendectomy	Gastrointestinal disorders	—	—	—	—	—
Hopsitalized with DVT	Vascular disorders	—	—	—	—	—
Hopsitalized for rectal bleeding	Gastrointestinal disorders	—	—	—	—	—

Most-reported serious reactions: Back Surgery, COVID Hospitalization, Musculoskeletal Injury or Fracture, Hopsitalization following accident, Hospitalized for abdominal pain, Hospitalized for Chest Pain, Hopsitalized for Osteomyelitis of humerus, Appendectomy.

Data from ClinicalTrials.gov NCT03859713 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Relationship Between Neighborhood Deprivation and Perceived Changes for Pain-Related Experiences Among US Patients with Chronic Low Back Pain During the COVID-19 Pandemic.
   Rassu FS, McFadden M, Aaron RV, Wegener ST, et al · · 2021 · cited 20× · PMID 34181008 · DOI 10.1093/pm/pnab179
2. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.
   Skolasky RL, Wegener ST, Aaron RV, Ephraim P, et al · · 2020 · cited 19× · PMID 32393216 · DOI 10.1186/s12891-020-03324-z
3. Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain.
   Fritz JM, Lane E, Minick KI, Bardsley T, et al · · 2021 · cited 17× · PMID 34927165 · DOI 10.1089/tmr.2021.0028
4. Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME).
   Fritz JM, Greene T, Brennan GP, Minick K, et al · · 2023 · cited 2× · PMID 36823645 · DOI 10.1186/s13063-023-07150-1
5. Effectiveness of Nonpharmacologic Treatments for Chronic Low Back Pain : A Sequential, Multiple-Assignment, Randomized Trial.
   Fritz JM, Skolasky RL, Brennan G, Minick K, et al · · 2026 · PMID 42008809 · DOI 10.7326/annals-25-04645
6. Characterizing Modifications to a Comparative Effectiveness Research Study – the OPTIMIZE Trial - Using the framework for reporting adaptations and modifications to evidence-based interventions (FRAME)
   Greene T, Fritz JM, Brennan GP, Minick K, et al · · 2022 · DOI 10.21203/rs.3.rs-1719841/v1