Early Phase 1
N=71
Chronic Low Back Pain and Meditation
Pain
Bottom Line
View on ClinicalTrials.gov: NCT04034004 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Pain Ratings — 3.60; 4.69; 4.83; 5.41 units on a scale — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Mindfulness (Behavioral); Naloxone (Drug); Saline (Other); Meditation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Ratings |
3.60; 4.69; 4.83; 5.41; 4.13; 4.76 | .05 |
| SECONDARY Pain Catastrophizing Scale |
18.57; 20.83; 15.33; 18.48 | — |
| SECONDARY The Roland-Morris Disability Questionnaire (RMDQ) |
12.86; 13.85; 12.03; 14.02 | — |
| SECONDARY Brief Pain Inventory (BPI) |
4.47; 5.22; 3.94; 5.15; 4.40; 5.17 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04034004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.