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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT03594266
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years
* Able to understand the nature of the study and provide written informed consent
* Able to read, understand, and speak English
* Willing and able to comply with all study requirements, including all required procedures, phone calls and study visits
* Planned to undergo a commercial SCS trial of standard duration for the treatment of low back and/or leg pain with a commercially available SCS system as prescribed by a physician(s) according to FDA approved indications for use
* Planned utilization of preoperative antibiotics for SCS commercial trial
* Planned placement of two eight-electrode SCS trial leads (or at least one 16- electrode SCS trial lead) using a suitable technique for an extended trial (e.g. tunneling approach of a minimum of 3-4 cm, or buried lead trial) with at least one lead covering the T8 or T9 vertebral level
* Incoming Numerical Rating Scale (NRS) for pain (overall) of at least 6 (collected prior to the commercial trial)
* Passed psychological evaluation
* Negative MRSA screening result
* Negative MSSA screening result or documentation of subsequent decolonization routine if MSSA positive
* For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 7.5%
Exclusion Criteria:
* Enrolled in any investigational SCS stimulation trial, for which the SCS system is not commercially available
* Presence of any life-threatening, underlying illness separate from their indication for SCS therapy
* Patients reporting pregnancy at the time of enrollment
* Patients with poor compliance for pain management regimen
* Patients currently involved in an active workers compensation claim and/or active litigation related to injury associated with indication for SCS
* Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to baseline data collection
* Patients with an implanted pacemaker, defibrillator, or other medical contraindications for SCS therapy
* Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator
* Patients immunocompromised and/or at high risk for infection
* Patients with morphine equivalent dose \> 120 units
* Patients with documented history of allergic response or sensitivity to material(s) required for the study (e.g. silver impregnated antibacterial dressing, adhesives, titanium, silicone, etc.)
* Patients with a documented history of clostridium difficile
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03594266
Study Brief:
Protocol Section:
NCT03594266