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  • Research & Results
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  • Managing Long-Term Low Back Pain to I...

Managing Long-Term Low Back Pain to Improve Health and Reduce Reliance on Opioid Medicines: Comparing Mindfulness Meditation and Cognitive Behavioral Therapy -- Strategies To Assist with Management of Pain (STAMP)

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Project Summary  

PCORI has identified opioid use for chronic pain as an important research topic. Patients, clinicians, and others want to learn: How can patients lower their use of opioid medications while managing chronic pain, or eliminate use of these drugs altogether? To help answer this question, PCORI launched a funding initiative in 2016 on Clinical Strategies for Managing and Reducing Long Term Opioid Use for Chronic Pain. This research project is one of the studies PCORI awarded as part of this program.

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?

One in four US adults have chronic low back pain, which is defined as any type of pain in the low back or radiating down to the legs (sciatica) that lasts for three or more months. Chronic low back pain can make it difficult to do daily activities such as walking, sitting, or climbing stairs. Doctors often cannot cure chronic low back pain, but they may prescribe an opioid medicine to help patients manage their pain. These medicines can have serious side effects, such as addiction to the medicine, depression, or even death from accidental overdose. Because of these side effects, patients, families, and doctors want to learn about other ways patients can safely manage chronic low back pain and reduce or eliminate the use of opioid medicines.

This study compares two ways to help patients reduce chronic low back pain and improve their quality of life:

  • Mindfulness meditation helps people train their minds to focus attention in a certain way to cope with and reduce negative reactions to pain.
  • Cognitive behavioral therapy, a type of psychological therapy, helps people learn how to change their thoughts and feelings about pain and develop new ways to think and act when they are in pain.

Who can this research help?

This research can help people who have chronic low back pain, their families, and their doctors make choices about how to treat chronic low back pain.

What is the research team doing?

The research team is recruiting 766 people with chronic low back pain who currently are taking an opioid medicine.

The researchers are assigning participants by chance to one of two groups. The first group receives training in mindfulness meditation. The second group receives training in cognitive behavioral therapy. Participants learn these techniques during two-hour weekly group sessions for eight weeks and practice the techniques at home.

The research team is following people in both groups for a year to see which group reports less pain; better ability to perform basic functions such as walking, climbing stairs, and being physically active; better quality of life; and taking less opioid medicine. Researchers also are interviewing people in the study to learn more about how the treatments affect their chronic low back pain.

The research team includes patients with chronic low back pain, their family members, clinicians, and researchers. Patients on the research team are helping the researchers decide what to ask the study participants about their experiences.

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults with chronic low back pain who take a daily opioid medicine
Interventions/
Comparators
  • Mindfulness meditation
  • Cognitive behavioral therapy
Outcomes

Primary: reduced pain levels and increased function

Secondary: improved quality of life, reduced reliance on opioid medicine

Timeframe 12-month follow-up for primary outcome

Journal Articles

Related Articles

The Clinical Journal of Pain

The Impact of Psychological Interventions on Posttraumatic Stress Disorder and Pain Symptoms: A Systematic Review and Meta-Analysis

Engagement Resources

"How the PAC is Making a Difference" Template

STAMP Stakeholder Advisory Committee Meeting Agenda

STAMP Patient Family Advisory Committee Meeting Agenda

Project Details

Principal Investigator
Aleksandra Zgierska, MD, PhD
Project Status
In progress; Recruiting
Project Title
A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain
Board Approval Date
July 2016
Project End Date
June 2022
Organization
University of Wisconsin-Madison
Year Awarded
2016
State
Wisconsin
Project Type
Research Project
Health Conditions  
Mental/Behavioral Health
Addiction/Substance Abuse
Anxiety
Depression
Muscular and Skeletal Disorders
Chronic Back Pain
Neurological Disorders
Chronic Pain
Multiple/Comorbid Chronic Conditions
Intervention Strategies
Behavioral Interventions
Complementary and Alternative Medicine
Other Clinical Interventions
Training and Education Interventions
Populations
Racial/Ethnic Minorities
Women
Urban
Funding Announcement
Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain
Project Budget
$8,430,231
Study Registration Information
HSRP20164149
NCT03115359

Partners

Patient/Caregiver Partners

  • Penney Cowan, American Chronic Pain Association®
  • Earl Bailey; Kristin Wurtz-Hernandez

Other Stakeholder Partners

  • Russell Lemmon, University of Wisconsin-Madison Department of Family Medicine and Community Health
  • Chantelle Thomas, University of Wisconsin-Madison Department of Family Medicine and Community Health; Access Community Health Centers
  • Cheryl Wittke, Safe Communities®
Page Last Updated: 
February 20, 2020

Research & Results

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Meetings & Events

March 2
Cycle 1 2021 PCORnet Phase 3 Applicant Town Hall
March 8
Engagement Awards 2021 Special Cycle -- Applicant Office Hours (One)
March 15
Priorities on the Health Horizon: Informing PCORI's Strategic Plan (Webinar)

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Phone: (202) 827-7700 | Fax: (202) 355-9558
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