Optimize Low Back Pain

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.

Conditions

• Low Back Pain
• Chronic Pain

Interventions

BEHAVIORAL

Physical Therapy

Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

BEHAVIORAL

Cognitive Behavioral Therapy

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

BEHAVIORAL

Mindfulness

Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.

BEHAVIORAL

Phase I Treatment

Includes all participants receiving any Phase I intervention

BEHAVIORAL

Phase II Switching

Includes all participants receiving Switching as Phase II intervention

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Utah

  lead OTHER

Principal Investigators

• Julie Fritz, PT, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-22

Primary Completion

2024-10-01

Completion

2024-10-01

Countries

• United States

Study Locations