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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06546956
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18-70 years of age.
* Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months.
* Average pain intensity of ≥ 4/10 for the past month.
* Fluent in English.
* Access to internet with a valid email address.
* Able to lay down and stay relatively still for one hour.
Exclusion Criteria:
* Leg pain, or any other chronic pain, that is greater than low back pain.
* Back pain possibly due to specific conditions (e.g., cancer, infection).
* Ongoing legal action or disability claim related to low back pain.
* Neurological symptoms associated with low back pain, including loss of control or incontinence of bowel or bladder.
* Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
* Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
* Activity limiting heart disease including cardiovascular or peripheral arterial disease.
* Uncontrolled hypertension (i.e. SBP/DBP of \> 160/95) or orthostatic hypotension (e.g., issues with fainting).
* Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury.
* Serious acute physical injuries or any surgery within the past 6 months.
* Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiring hospitalization within the past 12 months or currently on anti-psychotic medications.
* History of hospitalization or treatment of substance use disorder within the past 12 months.
* Currently undergoing curative or palliative chemotherapy or radiation. Pregnant or plan to become pregnant during the study period.
* Glaucoma or detached retina.
* Current participation or participation in the past 2 months of an interventional research study.
* Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06546956
Study Brief:
Protocol Section:
NCT06546956