Meditation-CBT for Opioid-treated Chronic Low Back Pain

Completed · Phase 1/Phase 2

Conditions studied: Chronic Pain, Low Back Pain

In brief

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.

Key facts

Study ID

NCT01775995

Run by

University of Wisconsin, Madison

People needed

35

Starts

2013-01-01

Expected to finish

2013-12-01

Last updated by the study team

2016-05-16

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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