A Prospective Single-center Pilot Study on the Use of Closed-loop Spinal Cord Stimulation to Treat Chronic Pain Associated With Raynaud's Phenomenon.

Autor: Maciaczyk J; Department of Stereotactic and Functional Neurosurgery, University Hospital Bonn, Bonn, Germany; Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. Electronic address: jaroslaw.maciaczyk@ukbonn.de., Bara G; Department of Stereotactic and Functional Neurosurgery, University Hospital Bonn, Bonn, Germany., Basilaia B; Department of Stereotactic and Functional Neurosurgery, University Hospital Bonn, Bonn, Germany., Abuassi M; Department of Stereotactic and Functional Neurosurgery, University Hospital Bonn, Bonn, Germany., Dietz BE; Research, Saluda Medical, Harrogate, United Kingdom., Mugan D; Research, Saluda Medical, Harrogate, United Kingdom., Mayr A; Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany., Staerk C; Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany., Karakostas P; Departments of Rheumatology and Clinical Immunology, and Internal Medicine III, University Hospital Bonn, Bonn, Germany., Schäfer VS; Departments of Rheumatology and Clinical Immunology, and Internal Medicine III, University Hospital Bonn, Bonn, Germany.
Jazyk: angličtina
Zdroj: Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2024 Dec; Vol. 27 (8), pp. 1457-1469. Date of Electronic Publication: 2024 Oct 22.
DOI: 10.1016/j.neurom.2024.08.005
Abstrakt: Objectives: Raynaud's phenomenon (RP) is a vascular disorder characterized by episodic peripheral artery vasospasms, resulting in paleness, cyanosis, and/or erythema. There are few reports, mostly case reports, on the benefits of spinal cord stimulation (SCS) for the treatment of RP. However, there is a lack of objective evidence on SCS-induced modulation of the sympathetic system (eg, vasodilation) in this condition. We hypothesize that evoked compound action potential-controlled closed-loop SCS may relieve pain, reduce the severity and frequency of Raynaud attacks, and improve peripheral blood flow.
Materials and Methods: This prospective, observational, single-center pilot study aimed to evaluate the effectiveness of SCS in treating primary and secondary RP. Patient outcomes such as pain, Raynaud severity/condition score, Cochin Hand Function Scale, Scleroderma Health Assessment Questionnaire RP visual analog scale, EQ-5D-5L, Patient Global Impression of Change, blood flow assessments, and neurophysiological measurements were collected at baseline, trial end, one month, three months, and six months.
Results: Ten patients were successfully enrolled in the study and underwent epidural electrode placement for SCS. SCS resulted in a significant improvement in the severity of RP attacks (severity difference from baseline at trial end: -1.8, 95% CI, -3.1 to -0.5; p = 0.01; at one month: -2.1; 95% CI, -3.4 to -0.8; p = 0.004; at three months: -2.9; 95% CI, -4.2 to -1.6; p = 0.0002) and Raynaud condition score (difference from baseline at trial end: -2.1; 95% CI, -3.3 to -0.9; p = 0.002; at one month: -2.2; 95% CI, -3.4 to -1.0; p = 0.002; at three months: -3.3; 95% CI, -4.6 to -2.1; p = 0.00002; at six months: -4.1; 95% CI, -5.4 to -2.8; p = 0.0000008), and an objective reduction in peripheral occlusion and ulceration. While one of the combined primary end points was successfully achieved in terms of severity at the three-month follow-up, it is worth noting that the primary end point related to frequency improvement was not met during the same time frame.
Conclusions: This pilot study offers evidence linking SCS with the activation of large, myelinated fibers within the dorsal column in patients with RP. This activation is associated with improvement in the number of patient-related outcomes and enhanced peripheral circulation.
Competing Interests: Conflict of Interest Jarek Maciaczyk receives speaker fees from Boston Scientific, Saluda Medical, and Nevro; is a member of advisory boards of Boston Scientific, Saluda Medical, and Nevro; and has received research grants from Mainstay and Saluda Medical. Valentin S. Schäfer receives speaker fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Chugai, Celgene, Hexal, Janssen, Eli Lilly, Medac, Novartis, Onkowissen, Pfizer, Roche, Royal College of Physicians, Rheumaakademie, Sanofi, Takeda, and UCB; is an advisory board member for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Chugai, Gilead, Hexal, Eli Lilly, Medac, Novartis, Pfizer, Roche, and Sanofi; and receives research support from Boehringer Ingelheim, Celgene, Hexal, Universität Bonn, Eli Lilly, Novartis, Roche, and Alexion. Birte E. Dietz and Dave Mugan are employed by Saluda Medical. The remaining authors reported no conflict of interest.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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