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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT04888494
Eligibility Criteria:
Inclusion Criteria:
* ≥ 6 months of back pain on a daily basis;
* male or female with no racial or ethnic restrictions;
* 18 to 75 years old;
* average back pain intensity \> 4/10 at study entry;
* must be able to read, understand, and sign consent form;
* generally healthy.
Exclusion Criteria:
* back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
* history of tumor in the back;
* back surgery within the past 6 months;
* Chronic neurologic conditions, e.g., Parkinson's
* involvement in litigation regarding back pain;
* other severe medical diseases;
* pregnancy;
* positive urinary screen for any recreational drugs,
* opioids use;
* use of anticoagulants (low dose ASA allowed);
* history of gastric ulcer; renal insufficiency or congestive heart failure,
* contraindication to MRI,
* contraindication to TMS; including history of seizure/epilepsy\*
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
* Diagnosis of major depression;
* Intra-axial implants (e.g. spinal cord stimulators or pumps)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04888494
Study Brief:
Protocol Section:
NCT04888494