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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05837234
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
2. Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
3. Is currently considered medically stable as judged by investigator.
4. Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
5. Determined to be a good surgical candidate by the investigator.
6. Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
7. Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
8. Able to comply with study requirements and attend all scheduled visits.
9. Eighteen (18) years of age or older.
10. Literate, able to speak English and able to complete questionnaires independently.
Exclusion Criteria:
1. Diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at Baseline.
2. Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
3. Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
4. Opioid usage with average total daily morphine equivalent dose (MED) of \>60 mg.
5. A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
6. Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
7. Subject is participating in another interventional clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05837234
Study Brief:
Protocol Section:
NCT05837234