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Recruiting NCT05607381

Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

No phase Interventional Low Back Pain Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meditation, Usual care.
Who it may be relevant to
Registry conditions: Low Back Pain, Opioid Use. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain

Overview

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Detailed description

The trial is powered to detect an effect on the primary outcome with 150 participants with complete pre-post data; additional participants are enrolled to account for approximately 25% attrition.

Interventions

  • Behavioral Meditation
    Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
  • Other Usual care
    Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

Primary outcome measures

  • Blood oxygenation level dependent (BOLD) signaling [Time frame: At baseline and at post-treatment (8 weeks)]
Secondary outcome measures (7)
  • Visual Analog Scale Pain Ratings [Time frame: At baseline and at post-treatment (8 weeks)]
  • Chronic pain symptoms [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]
  • Opioid dose [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]
  • Pain catastrophizing [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]
  • Self-transcendence [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]
  • Mindful reinterpretation of pain sensations [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]
  • Trait mindfulness [Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up]

Eligibility criteria

Inclusion criteria

1\) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.

Exclusion criteria

1\) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of California, San Diego — La Jolla
  • Center on Mindfulness and Integrative Health Intervention Development — Salt Lake City

Identifiers

NCT: NCT05607381 · IRB_00133405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗