Meditation-CBT for Opioid-treated Chronic Low Back Pain

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Chronic Pain
Low Back Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01775995
2012-0656

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems