TY - JOUR
T1 - Effectiveness and Safety of Dorsal Root Ganglion Stimulation for the Treatment of Chronic Pain
T2 - A Pooled Analysis
AU - Huygen, Frank J. P. M.
AU - Kallewaard, Jan Willem
AU - Nijhuis, Harold
AU - Liem, Liong
AU - Vesper, Jan
AU - Fahey, Marie E.
AU - Blomme, Bram
AU - Morgalla, Matthias H.
AU - Deer, Timothy R.
AU - Capobianco, Robyn A.
N1 - Publisher Copyright:
© 2019 Abbott. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.
PY - 2020/2
Y1 - 2020/2
N2 - IntroductionSince it became available in the mid-2010s, dorsal root ganglion (DRG) stimulation has become part of the armamentarium to treat chronic pain. To date, one randomized controlled trial, and several studies of moderate sample size and various etiologies have been published on this topic. We conducted a pooled analysis to investigate the generalizability of individual studies and to identify differences in outcome between chronic pain etiologic subgroups and/or pain location.Materials and MethodsOne prospective, randomized comparative trial and six prospective, single-arm, observational studies were identified that met pre-defined acceptance criteria. Pain scores and patient-reported outcome (PRO) measures were weighted by study sample sizes and pooled. Safety data are reported in aggregate form.ResultsOur analysis included 217 patients with a permanent implant at 12-month follow-up. Analysis of pooled data showed an overall weighted mean pain score of 3.4, with 63% of patients reporting >= 50% pain relief. Effectiveness sub-analyses in CRPS-I, causalgia, and back pain resulted in a mean reduction in pain intensity of 4.9, 4.6, and 3.9 points, respectively. Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, 75% for leg, and 70% for back. A substantial improvement in all PROs was observed at 12months. The most commonly reported procedural or device complications were pain at the IPG pocket site, lead fracture, lead migration, and infection.ConclusionsDRG stimulation is an effective and safe therapy for various etiologies of chronic pain.
AB - IntroductionSince it became available in the mid-2010s, dorsal root ganglion (DRG) stimulation has become part of the armamentarium to treat chronic pain. To date, one randomized controlled trial, and several studies of moderate sample size and various etiologies have been published on this topic. We conducted a pooled analysis to investigate the generalizability of individual studies and to identify differences in outcome between chronic pain etiologic subgroups and/or pain location.Materials and MethodsOne prospective, randomized comparative trial and six prospective, single-arm, observational studies were identified that met pre-defined acceptance criteria. Pain scores and patient-reported outcome (PRO) measures were weighted by study sample sizes and pooled. Safety data are reported in aggregate form.ResultsOur analysis included 217 patients with a permanent implant at 12-month follow-up. Analysis of pooled data showed an overall weighted mean pain score of 3.4, with 63% of patients reporting >= 50% pain relief. Effectiveness sub-analyses in CRPS-I, causalgia, and back pain resulted in a mean reduction in pain intensity of 4.9, 4.6, and 3.9 points, respectively. Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, 75% for leg, and 70% for back. A substantial improvement in all PROs was observed at 12months. The most commonly reported procedural or device complications were pain at the IPG pocket site, lead fracture, lead migration, and infection.ConclusionsDRG stimulation is an effective and safe therapy for various etiologies of chronic pain.
KW - Causalgia
KW - complex regional pain syndrome type I
KW - dorsal root ganglion stimulation
KW - failed back surgery syndrome
KW - pooled analysis
KW - CLINICALLY IMPORTANT DIFFERENCE
KW - CHRONIC NEUROPATHIC PAIN
KW - SPINAL-CORD STIMULATION
KW - RESEARCH DESIGN CONSIDERATIONS
KW - LOW-BACK-PAIN
KW - SINGLE-CENTER
KW - GROIN PAIN
KW - OUTCOMES
KW - NEURONS
KW - INJURY
U2 - 10.1111/ner.13074
DO - 10.1111/ner.13074
M3 - Article
C2 - 31730273
SN - 1094-7159
VL - 23
SP - 213
EP - 221
JO - Neuromodulation
JF - Neuromodulation
IS - 2
ER -