Phase 2
N=35
Meditation-CBT for Opioid-treated Chronic Low Back Pain
Chronic Pain · Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01775995 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Health-Related Quality of Life: Averaged Pain Severity — -0.5; 0.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Meditation-CBT Intervention + Usual Care (Behavioral); Usual Care Alone (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-Related Quality of Life: Averaged Pain Severity |
-0.5; 0.5 | — |
| PRIMARY Health-Related Quality of Life: Averaged Pain Severity |
-0.5; 0.5 | — |
| PRIMARY Health-Related Quality of Life: Physical Function |
-5.0; 1.6 | — |
| PRIMARY Health-Related Quality of Life: Physical Function |
-5.0; 1.6 | — |
| SECONDARY Opioid Dose |
-10.1; -0.2 | — |
| SECONDARY Opioid Dose |
-10.1; -0.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01775995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.