Meditation-CBT for Opioid-treated Chronic Low Back Pain

Phase 1

Completed

Conditions: Chronic Pain
Low Back Pain

Interventions: Other: Usual Care Alone
Behavioral: Meditation-CBT Intervention + Usual Care

Registration Number: NCT01775995

Lead Sponsor: University of Wisconsin, Madison

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait-list Control	Usual Care Alone	Participants receiving usual care for CLBP and opioid therapy management.
Meditation-CBT	Meditation-CBT Intervention + Usual Care	Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life: Averaged Pain Severity	baseline to 26 weeks	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.
Health-Related Quality of Life: Physical Function	baseline to 26 weeks	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

Name	Time	Method
Opioid Dose	baseline to 26 weeks	Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose 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 daily opioid dose and negative values indicating decreased daily opioid dose.