BACKGROUND:Painful diabetic polyneuropathy (PDP) is associated with high pain scores and is difficult to treat. Therefore, spinal cord stimulation (SCS) has been suggested as second-line treatment. In this study, the feasibility and efficacy of SCS in PDP were investigated, as well as the predictive value of clinical sensory testing for the treatment outcome. METHODS:Fifteen patients with intractable PDP in the lower limbs were recruited. During lead implantation, the feasibility of achieving adequate paraesthesia coverage using one stimulation lead was investigated. If trial stimulation was successful, a definitive neurostimulator was implanted. Pain intensity was scored using an 11-point numeric rating scale and patients' global impression of change scale. Additionally, neuropathic pain characteristics, quality of life, sleep quality and mood were assessed. The predictive value of clinical sensory testing for the treatment outcome was analysed. RESULTS:Adequate paraesthesia coverage was achieved in 14 out of 15 patients. Clinically relevant pain relief was present in 11 patients after trial stimulation and 10 patients at 12 months. The quality of life was significantly increased at 2 weeks and 3 months in patients with successful SCS treatment. Several neuropathic pain characteristics and quality of sleep were improved at 2 weeks and 12 months. Preoperative clinical sensory testing did not differentiate between treatment responders from non-responders. CONCLUSIONS:SCS seems to be an efficacious and feasible treatment for intractable PDP. In this exploratory study, it was not possible to predict the treatment outcome using clinical sensory testing. These results justify performing a randomized clinical trial.
RCT Entities:
BACKGROUND: Painful diabetic polyneuropathy (PDP) is associated with high pain scores and is difficult to treat. Therefore, spinal cord stimulation (SCS) has been suggested as second-line treatment. In this study, the feasibility and efficacy of SCS in PDP were investigated, as well as the predictive value of clinical sensory testing for the treatment outcome. METHODS: Fifteen patients with intractable PDP in the lower limbs were recruited. During lead implantation, the feasibility of achieving adequate paraesthesia coverage using one stimulation lead was investigated. If trial stimulation was successful, a definitive neurostimulator was implanted. Pain intensity was scored using an 11-point numeric rating scale and patients' global impression of change scale. Additionally, neuropathic pain characteristics, quality of life, sleep quality and mood were assessed. The predictive value of clinical sensory testing for the treatment outcome was analysed. RESULTS: Adequate paraesthesia coverage was achieved in 14 out of 15 patients. Clinically relevant pain relief was present in 11 patients after trial stimulation and 10 patients at 12 months. The quality of life was significantly increased at 2 weeks and 3 months in patients with successful SCS treatment. Several neuropathic pain characteristics and quality of sleep were improved at 2 weeks and 12 months. Preoperative clinical sensory testing did not differentiate between treatment responders from non-responders. CONCLUSIONS: SCS seems to be an efficacious and feasible treatment for intractable PDP. In this exploratory study, it was not possible to predict the treatment outcome using clinical sensory testing. These results justify performing a randomized clinical trial.
Authors: Kasra Amirdelfan; Cong Yu; Matthew W Doust; Bradford E Gliner; Donna M Morgan; Leonardo Kapural; Ricardo Vallejo; B Todd Sitzman; Thomas L Yearwood; Richard Bundschu; Thomas Yang; Ramsin Benyamin; Abram H Burgher; Elizabeth S Brooks; Ashley A Powell; Jeyakumar Subbaroyan Journal: Qual Life Res Date: 2018-06-01 Impact factor: 4.147
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Authors: Erika A Petersen; Thomas G Stauss; James A Scowcroft; Elizabeth S Brooks; Judith L White; Shawn M Sills; Kasra Amirdelfan; Maged N Guirguis; Jijun Xu; Cong Yu; Ali Nairizi; Denis G Patterson; Kostandinos C Tsoulfas; Michael J Creamer; Vincent Galan; Richard H Bundschu; Neel D Mehta; Dawood Sayed; Shivanand P Lad; David J DiBenedetto; Khalid A Sethi; Johnathan H Goree; Matthew T Bennett; Nathan J Harrison; Atef F Israel; Paul Chang; Paul W Wu; Charles E Argoff; Christian E Nasr; Rod S Taylor; David L Caraway; Nagy A Mekhail Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2022-07-01
Authors: Eva Koetsier; Glenn Franken; Jacques Debets; Sander M J van Kuijk; Roberto S G M Perez; Bengt Linderoth; Elbert A J Joosten; Paolo Maino Journal: CNS Neurosci Ther Date: 2018-09-23 Impact factor: 5.243