Pilot-level Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01775995
First received: January 22, 2013
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

The goal of this pilot study is to develop and test a behavioral intervention to improve the health of adults with refractory chronic low back pain (CLBP) and reduce pain medication, especially prescription opioid use. CLBP is one of the most common, costly and disabling conditions, and is often refractory to treatment. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. This randomized controlled trial (RCT) will test the hypotheses (H) that at 26 weeks, meditation group participants (meditation + standard of care, SOC) compared to those in a wait-list control group (SOC alone) will:

H1: improve health-related quality of life (HRQoL) & reduce pain medication use.

H2: reduce alcohol and drug use and misuse

H3: show favorable benefit/cost ratio.

H4: improve stress-sensitive measures.


Condition Intervention Phase
Chronic Pain
Low Back Pain
Behavioral: Mindfulness Based Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot-level Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Physical Function [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]

    Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability "today".

    This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability.


  • Physical Function [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]

    Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability "today".

    This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability.



Secondary Outcome Measures:
  • Averaged Pain [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]

    Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.

    This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.


  • Averaged Pain [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]

    Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.

    This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.


  • Opioid Use [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]

    Opioid use was measured using the Timeline Followback Method which looked at the past 28 days of opioid use. Opioid use was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.

    This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased opioid use and negative values indicating decreased opioid use.


  • Opioid Use [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]

    Opioid use was measured using the Timeline Followback Method which looked at the past 28 days of opioid use. Opioid use was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.

    This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased opioid use and negative values indicating decreased opioid use.



Other Outcome Measures:
  • Stress-sensitive Measures [ Time Frame: 0, 8, 26 weeks ] [ Designated as safety issue: No ]
    We will assess stress using the following stress-sensitive outcome measures: a) the Perceived Stress Scale, Chronic Pain Assessment Questionnaire, Symptom Checklist-90R (anxiety, depression and global severity domains), and the Difficulties in Emotion Regulation Scale; b) biomarkers: the serum profile of stress-sensitive proinflammatory cytokines (electrochemiluminescence multiplex method) and C-reactive protein (Nephelometry); and c) Pain sensitivity and regulation (heat and cold stimuli, conditioned pain modulation paradigm).

  • Alcohol and Drug Use and Misuse [ Time Frame: 0, 8, 26 weeks ] [ Designated as safety issue: No ]
    Alcohol and drug use and misuse as assessed by: a) self-reported daily alcohol and/or drug use (# standard drinks/day; yes/no to drug use/day) over the past 28 days, (Timeline Follow-Back Method)); b) comprehensive toxicology assays conducted on blood, urine and saliva ("drug tests"); c) screening for substance use disorders will be conducted using validated questionnaires, the Alcohol Use Disorders Identification Test and the Drug Abuse Screening Test.

  • Benefit/Cost Ratio [ Time Frame: 0, 8, 26 weeks ] [ Designated as safety issue: No ]
    A benefit/cost ratio will be calculated using self-reported lost work time (number of days), health care utilization (number of clinic or emergency department visits; number of hospital days) and participant costs (number of minutes spent on intervention; pain medication cost, HRQoL) using a) the Economic Outcomes Survey and b) the HRQoL survey, the EuroQol EQ-5D-5L.

  • Health-Related Quality of Life Measures [ Time Frame: 0, 8, 26 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life measures Rand-MOS 36-item health survey and the EuroQol EQ-5D-5L


Enrollment: 35
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Meditation
Mindfulness Based Intervention + Standard of Care Therapy
Behavioral: Mindfulness Based Intervention
All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness based intervention. The intervention consists of an 8-week meditation course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week). Controls will be offered meditation intervention after completing the study.
Other Names:
  • Mindfulness Meditation
  • Meditation
  • Mindfulness
  • Chronic Low Back Pain
  • Cognitive Therapy
No Intervention: Wait-list Control
Standard of Care Therapy only

Detailed Description:

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP often includes opioid therapy even though it is often only marginally effective. Prescription opioid abuse is a national epidemic; development of safe, effective non-addictive therapies for chronic pain is a national priority. Mindfulness meditation is a promising, safe treatment for chronic pain, mental health and addictive disorders. No study has evaluated the potential of meditation to improve health, decrease daily pain medication, including opioid, dose or modify CLBP on a biological level in adults with opioid-treated refractory CLBP.

This unblinded 26-week pilot RCT will test methods feasibility and potential efficacy of meditation in improving health-related quality of life (HRQoL) and reducing daily pain medication, including opioid, use among opioid-treated CLBP adults. Up to 50 adults with daily CLBP, treated with daily opioids for at least 3 months, will be recruited from outpatient clinic and community settings, and randomly assigned to one of two balanced study arms: meditation + standard of care (SOC) or SOC alone (wait-list control). The CLBP-tailored meditation intervention will consist of a) therapist-led group training in meditation and evidence-based cognitive therapy strategies (two-hours/week for 8 weeks), and b) at-home meditation (30 minutes/day, 6 days/week). Controls will be offered meditation training after study completion.

Outcome measures at 0, 8 and 26 weeks will gather data on potential efficacy and mechanism of action of meditation intervention; stress reduction is hypothesized to be the primary mechanistic pathway: 1. CLBP-related HRQoL and self-reported pain medication use (primary outcomes); 2. Alcohol and drug use, and misuse; 3. Benefit/cost measures; and 4. Stress-responsive measures (self-reported psychological health measures, serum profile of stress-responsive biomarkers, and pain sensitivity and regulation measures).

This innovative study directly addresses national priorities aimed at development of an effective, safe treatment for CLBP and reduction of opioid use. Potential benefits accruing from positive findings include improved quality of life and reduced pain medication, especially opioid, use among patients with refractory CLBP which may result in decreased individual and societal harms that can be associated with opioid therapy; reduced pool of circulating opioids may help alleviate the growing problem of prescription opioid abuse.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 21 years old
  • Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica)
  • Pain lasting for and treated with clinician-prescribed daily opioids (≥ 30mg of morphine equivalent dose, MED) for ≥ 3 months
  • Has the ability to feel warm and cold temperature sensations in both hands
  • English fluent

Exclusion Criteria:

  • Experience in meditation (current, regular practice in the past 12 months or past formal training)
  • Inability to reliably participate
  • Self-reported current pregnancy
  • Preexisting delusional, bipolar, or borderline personality disorders
  • Individuals lacking consent capacity and prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775995

Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Aleksandra Zgierska, MD PhD University of Wisconsin, Madison
  More Information

Publications:
Dr. Zgierska was supported by the K23AA017508 from the National Institutes of Health (NIH) National Institute on Alcohol Abuse and Alcoholism (NIAAA). The project was also supported by the Clinical and Translational Science Award (CTSA) program through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01775995     History of Changes
Other Study ID Numbers: 2012-0656
Study First Received: January 22, 2013
Results First Received: November 26, 2014
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Chronic Pain
Low Back Pain

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 28, 2015