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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04236804
Eligibility Criteria:
Inclusion Criteria:
* Females or males 18 years of age and older at screening
* Diagnosis of Chronic Lower Back Pain (CLBP) and a \>50mg MME daily opioid dosage
* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
* Signed informed consent form
Exclusion Criteria:
* Subjects who, in the opinion of the study site principal investigator, have a psychotic disorder, dementia, or other issue which may make accurate data reporting difficult
* Subjects who do not speak fluent English
* Patient refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04236804
Study Brief:
Protocol Section:
NCT04236804