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Pain. 2017 Apr;158(4):669-681. doi: 10.1097/j.pain.0000000000000814.

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.

Author information

1
aCenter for Pain Relief, Charleston, WV, USA bMarcus Neuroscience Institute, Boca Raton, FL, USA cSt. Jude Medical, Sunnyvale, CA and Plano, TX, USA dUniversity of California, San Francisco, San Francisco, CA, USA eIPM Medical Group, Inc, Walnut Creek, CA, USA fNeurovations, Napa, CA, USA gPremier Pain Center, Shrewsbury Township, NJ, USA hHouston Pain Centers, Houston, TX, USA iHOPE Research-TPC, Phoenix, AZ, USA jHOPE Research-LVSP, Las Vegas, NV, USA kPain Management Associates, Independence, MO, USA lFlorida Pain, Merritt Island, FL, USA mCarolinas Pain Institute, Winston-Salem, NC, USA nNewport Beach Headache and Pain, Newport Beach, CA, USA oComprehensive Pain and Rehabilitation, Pascagoula, MS, USA pCleveland Clinic, Cleveland, OH, USA qHoly Cross Hospital, Ft. Lauderdale, FL, USA rEisenhower Medical Center, Rancho Mirage, CA, USA sSoutheastern Spine Institute, Mt. Pleasant, SC, USA tCoastal Pain Research, Carlsbad, CA, USA uDrug Studies America, Marietta, GA, USA vClinical Trials of South Carolina, Charleston, SC, USA wOrthopaedic Pain Specialists, Santa Monica, CA, USA.

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.

PMID:
28030470
PMCID:
PMC5359787
DOI:
10.1097/j.pain.0000000000000814
[Indexed for MEDLINE]
Free PMC Article

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