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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT03187132
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age 18 or older
4. Seeking care for a musculoskeletal injury
5. Experiencing pain greater than 3 out of 10 on a visual analog scale
6. English or Spanish speaking
7. Owns a compatible Android or iOS smartphone device (excluding tablets)
Exclusion Criteria:
1. Unable to understand the goals of the study due to cognitive difficulty
2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
3. Pregnant (contraindication for TENS unit)
4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
5. Hypersensitivity to flashing light or motion
6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03187132
Study Brief:
Protocol Section:
NCT03187132