title: Novel technique for trialing peripheral nerve stimulation: ultrasonography-guided StimuCath trial.
abstract: OBJECTIVE Peripheral nerve stimulation (PNS) has been used for the treatment of neuropathic pain for many decades. Despite the specific indications for PNS, clinicians often have difficulty screening for candidates likely to have a good or fair outcome. Given the expense of a permanent implant, most insurance companies will not pay for the implant without a successful PNS trial. And since PNS has only recently been approved by the US Food and Drug Administration, many insurance companies will not pay for a conventional trial of PNS. The objective of this study is to describe a short low-cost method for trialing and screening patients for peripheral nerve stimulator implantation. Additionally, this study demonstrates the long-term efficacy of PNS in the treatment of chronic neuropathic pain and the relative effectiveness of this novel screening method. METHODS The records of all patients who had undergone trialing and implantation of a PNS system for chronic refractory pain at the authors' institution over a 1-year period (August 1, 2012-July 31, 2013) were examined in this retrospective case series. The search revealed 17 patients, 13 who had undergone a novel in-office ultrasonography-guided StimuCath screening technique and 4 who had undergone a traditional week-long screening procedure. All 17 patients experienced a successful PNS trial and proceeded to permanent PNS system implantation. Patients were followed up for a mean duration of 3.0 years. Visual analog scale (VAS) pain scores were used to assess pain relief in the short-term (< 6 weeks), at 1 year, and at the last follow-up. Final outcome was also characterized as good, fair, poor, or bad. RESULTS Of these 17 patients, 10 were still using their stimulator at the last follow-up, with 8 of them obtaining good relief (classified as ≥ 50% pain relief, with an average 81% reduction in the VAS score) and 2 patients attaining fair relief (< 50% relief but still using stimulation therapy). Among the remaining 7 patients, the stimulator had been explanted in 4 and there had been no relief in 3. Excluding explanted cases, follow-up ranged from 14 to 46 months, with an average of 36 months. Patients with good or fair relief had experienced pain prior to implantation for an average of 5.1 years (range 1.8-15.2 years). A longer duration of pain trended toward a poorer outcome (bad outcome 7.6 years vs good outcome 4.1 years, p = 0.03). Seven (54%) of the 13 patients with the shorter trial experienced a good or fair outcome with an average 79% reduction in the VAS score; however, all 4 of the bad outcome cases came from this group. Three (75%) of the 4 patients with the longer trial experienced a good or fair outcome at the last follow-up, with an average 54% reduction in the VAS score. There was no difference between the trialing methods and the proportion of favorable (good or fair) outcomes (p = 0.71). CONCLUSIONS Short, ultrasonography-guided StimuCath trials were feasible in screening patients for permanent implantation of PNS, with efficacy similar to the traditional week-long screening noted at the 3-year follow-up.
authors.affiliation: Departments of 1 Neurosurgery and.
authors.forename: Chandan G
authors.initials: CG
authors.lastname: Reddy
authors.affiliation: Departments of 1 Neurosurgery and.
authors.forename: Oliver E
authors.initials: OE
authors.lastname: Flouty
authors.affiliation: Departments of 1 Neurosurgery and.
authors.forename: Marshall T
authors.initials: MT
authors.lastname: Holland
authors.affiliation: University of Iowa Carver College of Medicine, Iowa City, Iowa.
authors.forename: Leigh A
authors.initials: LA
authors.lastname: Rettenmaier
authors.affiliation: Departments of 1 Neurosurgery and.
authors.forename: Mario
authors.initials: M
authors.lastname: Zanaty
authors.affiliation: Anesthesiology.
authors.forename: Foad
authors.initials: F
authors.lastname: Elahi
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000000981:diagnostic imaging* / Q000628:therapy*; D012189:Retrospective Studies; D018084:Ultrasonography, Interventional / Q000379:methods*
keywords: DBS = deep brain stimulation; FDA = Food and Drug Administration; PNS = peripheral nerve stimulation; SCS = spinal cord stimulation; StimuCath; VAS = visual analog scale; minimally invasive; neuromodulation; peripheral nerve stimulation; ultrasound guidance