Meditation for Low Back Pain

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions.
Treatment for refractory CLBP often includes 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. No study has evaluated the potential of meditation to improve health, decrease
daily pain medication, including opioid, dose or modify CLBP on a biological level in adults
with opioid-treated refractory CLBP.

This unblinded 26-week pilot RCT will test methods feasibility and potential efficacy of
meditation in improving health-related quality of life (HRQoL) and reducing daily pain
medication, including opioid, use among opioid-treated CLBP adults. Up to 50 adults with
daily CLBP, treated with daily opioids for at least 3 months, will be recruited from
outpatient clinic and community settings, and randomly assigned to one of two balanced study
arms: meditation + standard of care (SOC) or SOC alone (wait-list control). The
CLBP-tailored meditation intervention will consist of a) therapist-led group training in
meditation and evidence-based cognitive therapy strategies (two-hours/week for 8 weeks), and
b) at-home meditation (30 minutes/day, 6 days/week). Controls will be offered meditation
training after study completion.

Outcome measures at 0, 8 and 26 weeks will gather data on potential efficacy and mechanism
of action of meditation intervention; stress reduction is hypothesized to be the primary
mechanistic pathway: 1. CLBP-related HRQoL and self-reported pain medication use (primary
outcomes); 2. Alcohol and drug use, and misuse; 3. Benefit/cost measures; and 4.
Stress-responsive measures (self-reported psychological health measures, serum profile of
stress-responsive biomarkers, and pain sensitivity and regulation measures).

This innovative study directly addresses national priorities aimed at 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 pain medication,
especially opioid, use among patients with refractory CLBP which may result in decreased
individual and societal harms that can be associated with opioid therapy; reduced pool of
circulating opioids may help alleviate the growing problem of prescription opioid abuse.

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

- 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