Status:
COMPLETED
Chronic Low Back Pain and Meditation
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 occ...
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 opi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04034004
Start Date
January 1 2021
End Date
December 22 2022
Last Update
October 11 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
2
UC San Diego Center for Mindfulness
San Diego, California, United States, 92122