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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT03445403
Eligibility Criteria:
Inclusion Criteria:
* Patients experiencing chronic pain defined as pain persisting for 3 months.
* Ages 10-17 years, both sexes and all races and ethnic groups.
* Patients with moderate pain rated as 5/10 and greater on a numeric rating scale of 0 to 10 points.
* English speaking.
* If patients are taking medications such as psychotropic (e.g., SSRI), opioid, anxiolytics or anticonvulsive drugs for pain such as gabapentinoids, they must be on stable doses for at least one week.
* Stable anxiety and depression.
Exclusion Criteria:
* Intermittent pain or pain of less than 3-month duration.
* Allodynia in the upper extremities
* Patients with poor understanding of English language or developmental disorders that affect the ability to reliably rate pain, read questionnaires and follow study instructions.
* Children and adolescents with a history of central nervous system, heart, kidney, liver, and respiratory system diseases.
* Psychiatric disorders such as conversion, bipolar disorder or psychosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT03445403
Study Brief:
Protocol Section:
NCT03445403