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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06306833
Eligibility Criteria:
Inclusion Criteria:
* Individuals who constantly experience low back pain for the last three months.
* Individuals who seek care from healthcare provider due to low back pain
* Individuals with average pain intensity, were assessed using the Brief Pain Inventory (BPI) over the past week ≥ 2 on a 0-10 scale.
* Individuals with an average Oswestry Disability Index (ODI) score ≥ 4.
* Individuals with State-Trait Anxiety Inventory (STAI) score ≥ 20.
Exclusion Criteria:
* Age below or above 25 and 75 years, respectively.
* Females who are pregnant, lactating, or that they anticipate becoming pregnant in the next 3-6 months will be excluded.
* Individuals having any diagnosed chronic disease.
* Individuals having any diagnosed neurological disorder including Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
* Individuals having any diagnosed motor disorder or had pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
* Individuals with an active cancer
* Blind individuals
* Individuals having a body mass index greater than 35 kg/m2
* Individuals with clinical depression, that is having a score of 24 or higher on the Center for Epidemiology Depression Scale.
* Individuals who have used narcotics or muscle relaxants within 30 days before study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT06306833
Study Brief:
Protocol Section:
NCT06306833