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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07123233
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Chronic Primary Orofacial Pain (CPOP) according to ICD-11 criteria.
* Patient-reported pain rating of 4 or higher out of 10 on the Brief Pain Inventory (BPI) question assessing average pain over the past week, consistent with inclusion criteria from previous chronic pain studies.
* Written informed consent.
* Age 18 years or older.
Exclusion Criteria:
* Age over 70 years.
* Current use of immunosuppressive medications (e.g., steroids).
* History of cancer (breast, thyroid, prostate, blood cancers, etc.).
* History of stroke, neurosurgical interventions, or brain tumors.
* History of specific inflammatory diseases (lupus, scleroderma, rheumatoid arthritis, polymyalgia rheumatica).
* History of psychiatric disorders such as schizophrenia, personality disorders, dissociative identity disorder, or other severe psychoses.
* Unexpected or unintentional weight loss of 10 kg or more in the year prior to recruitment.
* Difficulty participating due to logistical problems.
* Contraindications to undergoing functional magnetic resonance imaging (fMRI).
* Psychotherapy treatment of any kind within 15 months prior to the assessment date.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07123233
Study Brief:
Protocol Section:
NCT07123233