Chronic Pain, Failed Back Surgery Syndrome, Sciatica
Conditions
Brief summary
The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator. Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
Interventions
PROCEDUREAwake
Upon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions.
PROCEDURENon-Awake
The patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al. (Falowski et al., 2011).
Sponsors
Abbott Medical Devices
St. Luke's Hospital, Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility. * Sign informed consent
Exclusion criteria
* \< 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods | 24 weeks |
| Safety assessed by the number of adverse events | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pain Evaluation | 24 weeks |
| Pain Location | 24 weeks |
| Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation | 24 weeks |
Countries
United States
Outcome results
None listed