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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT04818606
Eligibility Criteria:
Inclusion Criteria:
1: Presence of previous diagnosis of LR
1a: Presence of lumbosacral radiculopathy/radiculitis symptoms that extend below the knee secondary to low back pain for greater than 6 weeks with a painDETECT score greater than 18 OR.
1b: Diagnosis of lumbosacral radiculopathy/radiculitis secondary to low back pain that extends below the knee, with symptoms present for greater than 6 weeks.
1b.1: ICD-10 codes used for diagnostic inclusion: M54.16, M54.17, M51.16, M51.17, M47.26, M47.27, M54.40, M54.41, M54.42, M99.53, M99.54, S34.21, S34.22, G54.4, and G55
2: At least 18 years of age and not older than 64 at the time of study enrollment.
3: Ability to read and understand English.
4: Willingness to be randomized to either an experimental or a control group.
5: Willingness to refrain from unnecessary or self-directed pain management/treatment plan changes during study enrollment and to report necessary changes made.
6: Daily access to the internet via cell phone, tablet, or computer.
Exclusion Criteria:
1. Epidural steroid injection in the prior 3 months.
2. Inability to complete 20 unassisted gait cycles.
3. Have received a surgical intervention for low back pain or lumbosacral radiculopathy/radiculitis within the previous 6 months.
4. Current active mindfulness meditation practice: 1 time/week or more and/or formal training in mindfulness/meditation practice.
5. Concurrent diagnosis of cancer.
6. Allergy or intolerance to adhesive.
7. Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia and schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04818606
Study Brief:
Protocol Section:
NCT04818606