title: Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.
abstract: Animal and human studies indicate that electrical stimulation of dorsal root ganglion (DRG) neurons may modulate neuropathic pain signals. ACCURATE, a pivotal, prospective, multicenter, randomized comparative effectiveness trial, was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities. Subjects received neurostimulation of the DRG or dorsal column (spinal cord stimulation, SCS). The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed through 12 months for long-term outcomes and adverse events. The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related neurological deficits. The percentage of subjects receiving ≥50% pain relief and treatment success was greater in the DRG arm (81.2%) than in the SCS arm (55.7%, P < 0.001) at 3 months. Device-related and serious adverse events were not different between the 2 groups. Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition. Finally, subjects using DRG stimulation reported less postural variation in paresthesia (P < 0.001) and reduced extraneous stimulation in nonpainful areas (P = 0.014), indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities. As the largest prospective, randomized comparative effectiveness trial to date, the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.
authors.affiliation: Center for Pain Relief, Charleston, WV, USA.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Deer
authors.affiliation: Marcus Neuroscience Institute, Boca Raton, FL, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Levy
authors.affiliation: St. Jude Medical, Sunnyvale, CA and Plano, TX, USA.
authors.forename: Jeffery
authors.initials: J
authors.lastname: Kramer
authors.affiliation: University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Poree
authors.affiliation: IPM Medical Group, Inc, Walnut Creek, CA, USA.
authors.forename: Kasra
authors.initials: K
authors.lastname: Amirdelfan
authors.affiliation: Neurovations, Napa, CA, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Grigsby
authors.affiliation: Premier Pain Center, Shrewsbury Township, NJ, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Staats
authors.affiliation: Houston Pain Centers, Houston, TX, USA.
authors.forename: Allen W
authors.initials: AW
authors.lastname: Burton
authors.affiliation: HOPE Research-TPC, Phoenix, AZ, USA.
authors.forename: Abram H
authors.initials: AH
authors.lastname: Burgher
authors.affiliation: HOPE Research-LVSP, Las Vegas, NV, USA.
authors.forename: Jon
authors.initials: J
authors.lastname: Obray
authors.affiliation: Pain Management Associates, Independence, MO, USA.
authors.forename: James
authors.initials: J
authors.lastname: Scowcroft
authors.affiliation: Florida Pain, Merritt Island, FL, USA.
authors.forename: Stan
authors.initials: S
authors.lastname: Golovac
authors.affiliation: Carolinas Pain Institute, Winston-Salem, NC, USA.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Kapural
authors.affiliation: Newport Beach Headache and Pain, Newport Beach, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Paicius
authors.affiliation: Center for Pain Relief, Charleston, WV, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Kim
authors.affiliation: Center for Pain Relief, Charleston, WV, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Pope
authors.affiliation: Comprehensive Pain and Rehabilitation, Pascagoula, MS, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Yearwood
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Samuel
authors.affiliation: Holy Cross Hospital, Ft. Lauderdale, FL, USA.
authors.forename: W Porter
authors.initials: WP
authors.lastname: McRoberts
authors.affiliation: Eisenhower Medical Center, Rancho Mirage, CA, USA.
authors.forename: Hazmer
authors.initials: H
authors.lastname: Cassim
authors.affiliation: Southeastern Spine Institute, Mt. Pleasant, SC, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Netherton
authors.affiliation: Coastal Pain Research, Carlsbad, CA, USA.
authors.forename: Nathan
authors.initials: N
authors.lastname: Miller
authors.affiliation: Drug Studies America, Marietta, GA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Schaufele
authors.affiliation: Clinical Trials of South Carolina, Charleston, SC, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Tavel
authors.affiliation: Orthopaedic Pain Specialists, Santa Monica, CA, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Davis
authors.affiliation: St. Jude Medical, Sunnyvale, CA and Plano, TX, USA.
authors.forename: Kristina
authors.initials: K
authors.lastname: Davis
authors.affiliation: St. Jude Medical, Sunnyvale, CA and Plano, TX, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Johnson
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Nagy
authors.initials: N
authors.lastname: Mekhail
mesh_terms: D000328:Adult; D000368:Aged; D002422:Causalgia / Q000628:therapy*; D020918:Complex Regional Pain Syndromes / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D005727:Ganglia, Spinal / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011569:Psychiatric Status Rating Scales; D055815:Young Adult