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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05540002
Eligibility Criteria:
Inclusion Criteria:
* Ages 21 and older
* Pain duration \> 3 months
* Diagnosed by physician with multiple chronic pain conditions
* Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)
* Average 4 or greater on pain intensity scale of 0 to 10
* Pain is not accounted for by any other progressive disease (e.g., cancer, MS)
* Meets sensory hypersensitivity cutoffs based on QST-assessed evidence
* Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device
* Able to speak and understand English
Exclusion Criteria:
* Diagnosis of cancer or any other malignant disease
* Acute osteomyelitis or acute bone disease
* Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
* Pregnancy
* Any clinically unstable systemic illness judged to interfere with treatment
* A pain condition requiring urgent surgery
* An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation
* Have an implanted cardiac pacemaker, defibrillator, or other implanted device.
* Reynaud's syndrome
* Open cuts/sores
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT05540002
Study Brief:
Protocol Section:
NCT05540002