Meditation-CBT for Opioid-treated Chronic Low Back Pain

NCT01775995 | Completed Phase 1 Results

• 1 other identifier: 2012-0656
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It is often refractory to treatment, with patients requiring long-term opioid therapy. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.

Conditions

Chronic Pain; Low Back Pain

Keywords

Chronic Pain; Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Health-Related Quality of Life: Averaged Pain Severity

  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.

  baseline to 8 weeks

• Health-Related Quality of Life: Averaged Pain Severity

  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.

  baseline to 26 weeks

• Health-Related Quality of Life: Physical Function

  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.

  baseline to 8 weeks

• Health-Related Quality of Life: Physical Function

  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.

  baseline to 26 weeks

Secondary Outcomes (2)

• Opioid Dose

  baseline to 8 weeks

• Opioid Dose

  baseline to 26 weeks

Other Outcomes (23)

• Alcohol Use

  Baseline

• Alcohol Use

  8 weeks

• Alcohol Use

  26 weeks

Study Arms (2)

Meditation-CBT

EXPERIMENTAL

Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.

Behavioral: Meditation-CBT Intervention + Usual Care

Wait-list Control

OTHER

Participants receiving usual care for CLBP and opioid therapy management.

Other: Usual Care Alone

Interventions

Meditation-CBT Intervention + Usual Care BEHAVIORAL

The intervention combines meditation and standard-of-care CBT strategies for chronic low back pain. It consists of eight weekly 2-hour group sessions guided by trained instructors. In addition to session attendance, experimental participants are asked to practice meditation at home at least 6 days/week, 30 minutes/day during the 26-week study. Control participants will be offered the intervention after completing the study. All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Also known as: Mindfulness Meditation, Meditation, Mindfulness, Usual care, Cognitive Behavioral Therapy

Meditation-CBT

Usual Care Alone OTHER

All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Wait-list Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (for pain psychophysical testing)
• English fluent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.

  PMID: 26968850 DERIVED

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Interventions

Mindfulness; Meditation; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy

Limitations and Caveats

Lack of blinding of study staff to group status (except the statistician who was blinded during initial primary analyses); conducting most study related activities by the same core group of research staff may have introduced bias and placebo effect.

Results Point of Contact

• Title: Aleksandra Zgierska, MD PhD
• Organization: University of Wisconsin Madison

aleksandra.zgierska@fammed.wisc.edu

(608) 263-7882

Study Officials

• Aleksandra Zgierska, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2016
• Results First Posted: December 4, 2014

Record last verified: 2016-04

Locations

US (1)