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Benefit of Spinal Cord Stimulation for Patients with Central Poststroke Pain

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Benefit of Spinal Cord Stimulation for Patients with Central Poststroke Pain CLINICAL ARTICLE Benefit of spinal cord stimulation for patients with central poststroke pain: a retrospective multicenter study Koichi Hosomi, MD, PhD,1,2 Takamitsu Yamamoto, MD, PhD,3 Takashi Agari, MD, PhD,4,5 Shinichiro Takeshita, MD, PhD,6 Takafumi Tanei, MD, PhD,7 Hirochika Imoto, MD, PhD,8 Nobuhiko Mori, RPT, MHSc,1,2 Satoru Oshino, MD, PhD,2 Kaoru Kurisu, MD, PhD,9 Haruhiko Kishima, MD, PhD,2 and Youichi Saitoh, MD, PhD1,2 Departments of 1Neuromodulation and Neurosurgery and 2Neurosurgery, Osaka University Graduate School of Medicine, Osaka; 3Department of Neurological Surgery, Nihon University School of Medicine, Tokyo; 4Department of Neurosurgery, Tokyo Metropolitan Neurological Hospital, Tokyo; 5Department of Neurological Surgery, Kurashiki-Heisei Hospital, Okayama; 6Department of Neurosurgery and Neuroendovascular Therapy, Hiroshima Prefectural Hospital, Hiroshima; 7Department of Neurosurgery, Komaki City Hospital, Aichi; 8Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi; and 9Department of Neurosurgery, Chugoku Rosai Hospital, Hiroshima, Japan OBJECTIVE Spinal cord stimulation (SCS) has been considered an ineffective procedure for patients with central post- stroke pain (CPSP). However, recent case series that included small numbers of patients reported the possible efficacy of SCS as a treatment of CPSP. This multicenter retrospective study aimed to examine the outcomes of using SCS to treat patients with CPSP and to explore factors related to outcomes. METHODS The authors reviewed the medical records of patients with CPSP who underwent SCS to collect data regarding their background, surgical information, and outcomes of SCS at trial stimulation and last follow-up after long- term implantation in six study centers. Outcomes were evaluated with a pain score for intensity (range 0–10) and the Patient Global Impression of Changes (PGIC) scale. Factors associated with outcomes were explored with univariable and multivariable analyses. RESULTS The authors collected data from a total of 166 patients (mean age 63.4 years; mean pain score at baseline 8.2). Of these patients, 163 underwent trial stimulation. The mean pain score decreased by 42.0%, 104 (64%) patients had ≥ 30% decrease in pain score, and 96 (59%) reported much or very much improved condition on the PGIC scale at trial stimulation. Moreover, 106 (64%) patients underwent long-term implantation of SCS devices. The mean decrease in pain score was 41.4%, 63 (59%) patients continued to show ≥ 30% decrease in pain score at last follow-up, and 60 (56%) reported much or very much improved condition on the PGIC scale at last follow-up (median [range] follow-up period 24 [24–63] months). Eleven device-related complications and 10 permanent explantations were observed. Uni- variable and multivariable analyses suggested that young age, less sensory disturbance, implantation of cervical leads, treatment of upper-limb pain, and extensive treated regions were associated with satisfactory outcomes at last follow-up after long-term implantation. CONCLUSIONS These findings indicate that SCS may modestly benefit patients with CPSP. SCS has therapeutic po- tential for patients with intractable CPSP owing to the lower invasiveness of the SCS procedure and refractory nature of CPSP. Nevertheless, trial stimulation is necessary because of the high initial failure rate. https://thejns.org/doi/abs/10.3171/2020.11.JNS202999 KEYWORDS spinal cord stimulation; central poststroke pain; long-term outcome; multicenter study; retrospective study; case series ENTRAL poststroke pain (CPSP), chronic neuro- the sensory thalamus, lenticulocapsular region, posterior pathic pain caused by cerebrovascular lesions of insular cortex, pons, and lateral medulla, after hemor- the central somatosensory nervous system, occurs rhagic or ischemic stroke. CPSP typically emerges several inC up to 10% of patients. The condition can result from any months after stroke. The clinical symptoms are similar to lesion of the somatosensory pathway, particularly those in those of other types of neuropathic pain and often persist ABBREVIATIONS CPSP = central poststroke pain; CRPS = complex regional pain syndrome; FBSS = failed back surgery syndrome; PGIC = Patient Global Impression of Changes; PNP = peripheral neuropathic pain; RCT = randomized controlled trial; SCS = spinal cord stimulation. SUBMITTED July 31, 2020. ACCEPTED November 16, 2020. INCLUDE WHEN CITING Published online July 2, 2021; DOI: 10.3171/2020.11.JNS202999. © 2021 The authors, CC BY-NC-ND 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/) J Neurosurg July 2, 2021 1 Unauthenticated | Downloaded 09/28/21 01:49 AM UTC Hosomi et al. throughout the patient’s life. The pain area can range from Welfare. The study protocol was approved by the IRB of half the body to restricted regions that correspond topo- each center or the central IRB of Osaka University Hospi- graphically to the stroke lesion.1,2 CPSP is typically dif- tal. The need for informed consent was waived by the IRB ficult to treat with conventional pharmacological means. because of the retrospective design of this study; however, Therefore, several neurostimulation therapies, such as spi- each center provided an option for patients to opt out of nal cord stimulation (SCS), deep brain stimulation, electri- the study. cal motor cortex stimulation, and repetitive transcranial magnetic stimulation, have been administered to patients Data Collection 2 with CPSP. Among these, SCS is less invasive owing to We reviewed the medical records of patients with the percutaneous procedures performed for trial stimula- CPSP who underwent SCS at the aforementioned centers tion and permanent implantation. and we collected the following data: patient background SCS is effective for intractable neuropathic pain after characteristics (sex, age at first surgery, stroke type, stroke spine surgery (failed back surgery syndrome [FBSS] and site, stroke side, pain duration, pain site, pain side, pain failed neck surgery syndrome), complex regional pain score at baseline, and previous therapy), surgical infor- syndrome (CRPS), peripheral neuropathic pain (PNP), 3–6 mation (whether trial stimulation was performed, target and pain associated with peripheral vascular disease. region of pain, and position of SCS lead[s]), outcomes However, SCS has been considered ineffective for CRPS. of SCS at trial stimulation and last follow-up after long- Simpson reported that SCS benefited 7 of 11 patients with 7 term implantation, and stimulation type at last follow-up. C PSP, whereas Katayama et al. reported that only 3 of 45 Outcomes were evaluated with pain intensity scores (nu- such patients had > 60% pain relief after long-term fol- 8 merical rating or visual analog scale [range 0–10]) and the low-up. Based on these results and the lack of high-level Patient Global Impression of Changes (PGIC) scale. The evidence, the guidelines of the European Federation of PGIC scale is a 7-point scale, ranging from “very much Neurological Societies3 and the consensus recommenda- 4 improved” to “very much worse.” Information regarding tions of the British Pain Society and the Neuropathic Pain follow-up duration and treatment complications in patients Special Interest Group of the International Association 5 with long-term implantation was also required. These data for the Study of Pain do not recommend application of were selected as required based on availability at our cen- SCS to patients with CPSP. However, recent single-center ters. Optional data included pain onset after stroke, pres- case series with small numbers of patients (range 6–30 ence of motor disturbance, sensory disturbance, allodynia, patients) have reported possible efficacy, with responder 9–12 and hyperpathia, number of SCS leads, and number of rates of 23%–83%. Because a study with a large num- contacts of the SCS leads. Degree of motor disturbance ber of patients is required to establish the efficacy of SCS was categorized on the basis of the score on the manual as a treatment of CPSP, we conducted a retrospective mul- muscle test as follows: 0–2, severe; 3, moderate; 4, mild; ticenter study in Japan. Thus, we report the outcomes of and 5, normal. Collected data were stored in REDCap ver- trial and long-term stimulation with SCS in patients with sion 8.10.20 (Vanderbilt University). CPSP and explore factors related to SCS outcomes. Decrease in pain score at trial stimulation and last follow-up was categorized as ≥ 50%, 30%–49%, and < Methods 30%. Decrease in pain score was calculated as follows: Study Centers and Patients decrease (%) = 100 − (pain score after surgery/pain score × We conducted a multicenter retrospective search for at baseline) 100. Efficacy thresholds were determined patients with CPSP treated with SCS. The following six on the basis of the clinical importance of change in pain: treatment centers in Japan, which have treated many pa- decreases of 50% and 30% corresponded to substantially and moderately important changes in pain intensity score, tients with CPSP with SCS, were included in the study: 13 Osaka University Hospital, Osaka; Nihon University respectively. Itabashi Hospital, Tokyo; Kurashiki-Heisei Hospital, Okayama; Hiroshima Prefectural Hospital and Hiroshima SCS Procedures University Hospital, Hiroshima; Komaki City Hospital, The surgical indication was medically refractory CPSP, Aichi; and Yamaguchi University Hospital, Yamaguchi, for which pharmacotherapy had failed. Surgical proce- Japan. Case series
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