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Strategies to Assist With Management of Pain (STAMP)

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ClinicalTrials.gov Identifier: NCT03115359
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring non-judgmental and accepting attention to present-moment experiences such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping improve health and well-being, and reduce reliance on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early research, including a pilot study by the Principal Investigator, evidence on MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap.

With input from patients, family members, and clinicians, the Investigators have designed a study to address this gap and propose a clinical trial that will compare the effectiveness of MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is hypothesized that MM training will lead to a larger reduction in pain intensity, increase in physical function, improvement in quality of life, and decrease in daily opioid dose, as compared to CBT training, with benefits of MM especially notable in adults with worse mood, anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP and less improvement in response to existing therapies.

To test these hypotheses, 766 adults with opioid-treated CLBP from Madison, WI, Boston, MA, and Salt Lake City, will be randomly assigned into one of two 8-week treatment groups: MM (383 participants) that will receive the MM training or CBT (383 participants) that will receive the CBT training. The effectiveness of MM versus CBT will be assessed over a 12-month period with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, including patients with opioid-treated CLBP, their families and clinicians.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Mindfulness Meditation Behavioral: Cognitive Behavioral Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 766 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative effectiveness randomized controlled trial of two behavioral interventions
Masking: Single (Investigator)
Masking Description: Although participants, therapists and outcome assessors cannot be blinded to the study intervention, investigators and analysts will be blinded to the group status until the first stages of analysis and reporting are completed.
Primary Purpose: Treatment
Official Title: A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Mindfulness Meditation
Mindfulness Meditation intervention, adjunctive to usual care for opioid-treated chronic low back pain.
Behavioral: Mindfulness Meditation

The Mindfulness Meditation intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study.

In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Other Names:
  • Meditation
  • Mindfulness

Active Comparator: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain.
Behavioral: Cognitive Behavioral Therapy

The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study.

In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Other Name: CBT




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Baseline to 12 months ]
    4 pain severity items from the Brief Pain Inventory

  2. Physical Function [ Time Frame: Baseline to 12 months ]
    10-item Oswestry Disability Index


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Baseline to 12 months ]
    12-item Short Form-12

  2. Daily Opioid Dose [ Time Frame: Baseline to 12 months ]
    Timeline Followback Method (morphine-equivalent dose [mg/day] over the prior 14 days)


Other Outcome Measures:
  1. Depression Symptom Severity [ Time Frame: Baseline to 12 months ]
    14-item Hospital Anxiety and Depression Scale

  2. Anxiety Symptom Severity [ Time Frame: Baseline to 12 months ]
    14-item Hospital Anxiety and Depression Scale

  3. Opioid Use Behaviors [ Time Frame: Baseline to 12 months ]
    17-item Current Opioid Misuse Measure

  4. Opioid Medication Compliance [ Time Frame: Baseline to 12 months ]
    8-item Opioid Compliance Checklist



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (per self-report): English-speaking; age ≥ 21 years old; chronic low back pain (defined as a pain in lumbosacral region or sciatica for ≥3 months), with an average daily back pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory), treated with ≥30 mg/day of morphine-equivalent dose for ≥3 months; at least moderate CLBP-related disability (≥21 score on the Oswestry Disability Index); capable of giving informed consent; willing to complete the study activities.

Exclusion Criteria (per self-report): prior formal Mindfulness Meditation or Cognitive Behavioral Therapy training; current pregnancy; diagnosis of borderline personality, delusional, or bipolar (mania) disorder; inability to safely or reliably participate in the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115359


Contacts
Contact: Cindy A Burzinski, MS 608-262-6549 cindy.burzinski@fammed.wisc.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christina McDonnell, MSc    617-732-9181    crmcdonnell@bwh.harvard.edu   
Principal Investigator: Robert Edwards, PhD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Rachel Atchley, PhD    801-581-8489    rachel.atchley@utah.edu   
Principal Investigator: Eric Garland, PhD         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53715
Contact: Cindy A Burzinski, MS    608-262-6549    cindy.burzinski@fammed.wisc.edu   
Principal Investigator: Aleksandra E Zgierska, MD PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Aleksandra E Zgierska, MD PhD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03115359     History of Changes
Other Study ID Numbers: 2017-0353
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries, programming codes, qualitative codebooks, and other study materials will be provided to the funding agency, Patient-Centered Research Outcomes Institute (PCORI) after the study completion in order to promote replication of the research process. A final, clean dataset will be available for data sharing after the project and analysis completion. PCORI may share these materials and data upon request, after consultation with the PI.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
Chronic Low Back Pain
Opioid Therapy
Chronic Pain
Mindfulness Meditation
Cognitive Behavioral Therapy
Opioid-treated Chronic Low Back Pain
CLBP

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Physiological Effects of Drugs
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents