Project Summary

PCORI has identified relief of low back pain as an important research topic. Patients, clinicians, and others want to know how physical, behavioral, pharmacologic, and complementary or alternative treatment approaches affect patients’ quality of life and other outcomes. To address this issue, PCORI launched an initiative in 2017 on Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain. The initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Low back pain is a common health problem among adults in the United States. For many adults, low back pain is temporary. For others, the pain doesn’t go away. Pain that lasts for months or years is called chronic low back pain. Adults with chronic low back pain may have trouble with daily activities such as sitting, walking, or climbing stairs. Back pain can also make working hard.

This study is comparing three ways to treat low back pain. Patients who don’t feel better after one treatment can try a different one. The three ways to treat low back pain are

  • Physical therapy, which focuses on improving movement and physical ability, educating patients, and relieving pain
  • Cognitive behavioral therapy, or CBT, a type of therapy that teaches people how to change their thoughts and feelings about pain and develop new ways to think and act when they are in pain
  • Mindfulness meditation helps people train their minds to focus attention in a certain way to cope with and reduce negative reactions to pain

Who can this research help?

Information from this study can help adults with chronic low back pain and their doctors when considering treatment options, especially if the first treatment doesn’t work. Health clinics can use this information when considering services to help adults with chronic low back pain.  

What is the research team doing?

The research team is recruiting 945 adults who have seen a doctor for low back pain in the past 90 days and have had low back pain for at least half the days in the past six months. Participants must be ages 64 or younger and they must report at least moderate pain and disability based on standard rating scales.

First, the research team is assigning patients by chance to have eight weeks of physical therapy or CBT. After 10 weeks, the team assigns by chance patients whose pain and function have not improved, either to the therapy they did not get the first time or to mindfulness training. Therapists in each group encourage patients to think about what they can do to stay in treatment and find ways to manage their back pain on their own.

Patients are filling out surveys at the start of the study and again after 10 weeks, 6 months, and 1 year. The surveys track their level of pain and disability, quality of life, fatigue, sleep, anxiety, depression, and social interactions. The research team is also looking at whether patients have had any side effects from their treatment, and whether patients need more clinic visits for their back pain or if they need opioids for long periods to manage their pain.  

Adults who have had chronic low back pain are working with the research team to plan the study. In addition, clinic leaders, insurance companies, and clinicians such as doctors and nurses are also working with the team.

Research methods at a glance

Design Elements Description
Design Sequential multiple assignment randomized trial (SMART) design
Population Adults ages 18–64 who have had low back pain for more than 3 months and have had low back pain at least half the days in the past 6 months; have had a healthcare visit for low back pain in the past 90 days; have a pain intensity rating ≥4 and an Oswestry Disability Index (ODI) score ≥24
Interventions/
Comparators
  • Physical therapy followed by CBT for those who don’t respond to physical therapy
  • Physical therapy followed by mindfulness training for those who don’t respond to physical therapy
  • CBT followed by physical therapy for those who don’t respond to CBT
  • CBT followed by mindfulness training for those who don’t respond to CBT
Outcomes

Primary: change in ODI score, change in numeric pain intensity rating

Secondary: health-related quality of life, pain interference, fatigue, sleep disturbance, anxiety, depression, social role participation, healthcare utilization, opioid utilization, treatment side effects, treatment response

Timeframe 1-year follow-up for primary outcomes

Project Information

Julie Fritz, PhD
University of Utah
$9,453,662

Key Dates

60 months
April 2018
March 2025
2018

Study Registration Information

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Last updated: November 15, 2021