Clinical trial NCT01775995: Meditation-CBT for Opioid-treated Chronic Low Back Pain
Official title: Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pain
Low Back Pain
Keywords: Chronic Pain
Low Back Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP includes long-term 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. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. No study has evaluated the potential of a combined meditation-CBT intervention to improve outcomes in patients with opioid-treated CLBP.

This unblinded 26-week pilot randomized controlled trial (RCT) will test methods feasibility and efficacy of meditation-CBT for improving health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome) among adults with opioid-treated CLBP. Eligible participants are adults at least 21 years old, with daily CLBP treated with daily opioids (at least 30 morphine-equivalent mg/day) for at least 3 months. They will be recruited from outpatient clinic and community settings, and randomly assigned to one of two study arms: meditation-CBT + usual care or usual care alone. The targeted meditation-CBT intervention will consist of a) therapist-led group training (two-hours/week for 8 weeks), and b) at-home meditation practice (at least 30 minutes/day, 6 days/week). Control participants will be offered the intervention after their study completion.

Outcome measures, collected at 0, 8 (directly post-intervention) and 26 (18 weeks post-intervention) weeks will gather data on efficacy and potential mechanisms of action of meditation-CBT intervention. 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. Increased pain acceptance, mindfulness level or stress reduction are hypothesized to be the mechanistic pathways.

This study directly addresses national priorities aimed at the 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 opioid pain medication use among patients with refractory, opioid-treated CLBP.

Eligibility 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 (for pain psychophysical testing)
* 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

Primary outcomes:
measure: Health-Related Quality of Life: Averaged Pain Severity
timeFrame: baseline to 8 weeks
measure: Health-Related Quality of Life: Averaged Pain Severity
timeFrame: baseline to 26 weeks
measure: Health-Related Quality of Life: Physical Function
timeFrame: baseline to 8 weeks
measure: Health-Related Quality of Life: Physical Function
timeFrame: baseline to 26 weeks
Secondary outcomes:
measure: Opioid Dose
timeFrame: baseline to 8 weeks
measure: Opioid Dose
timeFrame: baseline to 26 weeks
Other outcomes:
measure: Alcohol Use
timeFrame: Baseline
measure: Alcohol Use
timeFrame: 8 weeks
measure: Alcohol Use
timeFrame: 26 weeks
measure: Drug Use
timeFrame: Baseline
measure: Drug Use
timeFrame: 8 weeks
measure: Drug Use
timeFrame: 26 weeks
measure: Chronic Pain Acceptance
timeFrame: baseline to 8 weeks
measure: Chronic Pain Acceptance
timeFrame: baseline to 26 weeks
measure: Perceived Stress
timeFrame: baseline to 8 weeks
measure: Perceived Stress
timeFrame: baseline to 26 weeks
measure: Mental Health Symptom Severity
timeFrame: baseline to 8 weeks
measure: Mental Health Symptom Severity
timeFrame: baseline to 26 weeks
measure: Depression Symptom Severity
timeFrame: baseline to 8 weeks
measure: Depression Symptom Severity
timeFrame: baseline to 26 weeks
measure: Anxiety Symptom Severity
timeFrame: baseline to 8 weeks
measure: Anxiety Symptom Severity
timeFrame: baseline to 26 weeks
measure: Emotion Regulation Difficulty
timeFrame: baseline to 8 weeks
measure: Emotion Regulation Difficulty
timeFrame: baseline to 26 weeks
measure: C-Reactive Protein
timeFrame: baseline to 8 weeks
measure: C-Reactive Protein
timeFrame: baseline to 26 weeks
measure: Economic Outcomes
timeFrame: 6 months prior to baseline, to baseline (enrollment)
measure: Economic Outcomes
timeFrame: From enrollment to 26 week follow-up (6 months)
measure: Pain Sensitivity to Experimental Thermal Stimuli
timeFrame: 0, 8, 26 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Aleksandra Zgierska, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.