Clinical trial NCT04034004: Chronic Low Back Pain and Meditation
Official title: The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Mindfulness
Opioids
Pain
Naloxone
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-07-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

Detailed description: The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Eligibility criteria: Inclusion Criteria:

* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
* Participants must be between 18 and 65 years of age
* Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
* Participants must have experienced their chronic low back pain for at least 3 months
* Participants must have no prior meditative experience
* Participants must be straight leg raise test positive

Exclusion Criteria:

* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
* Participants must not be taking opioids
* Participants must not be pregnant or nursing mothers
* Participants must have not had back surgery within the last year before their enrollment into the study
* Participants must have not had any other sensory or motor deficits that preclude participation in this study
* Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
* Participants must not have any known allergies to naloxone or similar drugs
* Participants must not have a history of syncope and/or fear of needles/blood

Primary outcomes:
measure: Pain Ratings
timeFrame: Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.
measure: The Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.
measure: Brief Pain Inventory (BPI)
timeFrame: Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.
Other outcomes:
measure: SF-12 Health Survey (SF-12) Physical Functioning
timeFrame: Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: San Diego
country: United States
facility: UC San Diego Center for Mindfulness
state: California
Study officials:
affiliation: UC San Diego
name: Fadel Zeidan, PhD
role: PRINCIPAL_INVESTIGATOR
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