Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04034004
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04034004
Study Brief:
Protocol Section:
NCT04034004