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 @ 3:15 AM
Ignite Modification Date:
2025-12-25 @ 3:15 AM
NCT ID:
NCT06679205
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age.
* Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.
* Experiencing pain at least 50% of the time over the last 6 months.
* Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.
* Be agreeable to receiving active, non-pharmacological and non-surgical treatment.
Exclusion Criteria:
* Inflammatory low back pain.
* History of cancer in the last 5 years.
* Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.
* Lack of control of bowel and bladder function (cauda equina).
* Difficulty in performing the sessions due to severe physical disability.
* Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
* Strong prescription opioid or parenteral medication addiction disorders.
* Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).
* Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).
* Have sought compensation or entered into litigation in the preceding 12-month period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06679205
Study Brief:
Protocol Section:
NCT06679205