scholarly journals 24-month Real-World Study of Spinal Cord Stimulation in Failed Back Surgery Patients with Refractory Pain

2021 ◽  
Vol 24 (6) ◽  
pp. 479-488

BACKGROUND: Failed Back Surgery Syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to Conventional Medical Management (CMM) and Spinal Cord Stimulation (SCS) is advised. However, comparative effectiveness research of both clinical approaches still lacks further evidence. OBJECTIVES: This study describes Comparative Effectiveness Research of CMM versus SCS to provide real world evidence regarding the appropriate means for FBSS management, in terms of Patient-Reported Outcomes Measures. STUDY DESIGN: Naturalistic, pragmatic, prospective observational multicenter SEFUDOCE-study SETTING: FBSS patients attending clinical programmed visits in Pain Unit at Hospital Universitario de La Princesa and at Hospital General Universitario de Alicante (Spain). METHODS: Study evaluates the impact on pain, functional limitation, and HRQoL of CMM versus SCS in the management of FBSS. Patients completed Pain Detect Questionnaire, Oswestry Disability Index, EQ-5D-3L, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression Scale at baseline and at 3, 6, 12, 18 and 24 months. Longitudinal data were analysed with repeated-measures one-way analysis of variance adjusting by confounders. RESULTS: Eighty-five adults patients with FBSS receiving treatment according to current clinical practice were assessed. After 24 months, the PainDETECT Questionnnaire showed that CMM patients maintained similar scores, while SCS patients reduced their overall score (current pain: 6 CMM versus 4.21 SCS, P = 0.0091; intensity strongest pain: 7.77 CMM versus 6.07 SCS, P = 0.0103; average pain: 6.46 CMM versus 4.75 SCS, P = 0.0012). For the Oswestry Disability Index, the Medical Outcomes Study Sleep Scale, and the Hospital Anxiety and Depression Scale no significant inter-group differences were found. EQ-5D utility improved in SCS patients from baseline (baseline: 0.32 CMM versus 0.22 SCS; 24-month: 0.37 CMM versus 0.63 SCS, P = 0.026). Twenty-four month follow-up showed unlikely presence of neuropathic pain and moderate disability in SCS patients, whereas the CMM patients maintained baseline health state. LIMITATIONS: Given the nature of the intervention, conducting a blinded study was not considered practically feasible. A larger sample could also overcome having younger patients in the SCS arm. CONCLUSIONS: SCS may improve the HRQoL and functionality of FBSS patients with refractory pain in the long-term compared to CMM alone. KEY WORDS: Chronic pain management, conventional medical management, failed back surgery syndrome, observational study, spinal cord stimulation

2018 ◽  
Vol Volume 11 ◽  
pp. 1761-1767 ◽  
Author(s):  
Epifanio Mondello ◽  
Domenico Quattrone ◽  
Luigi Cardia ◽  
Giuseppe Bova ◽  
Raffaella Mallamace ◽  
...  

2021 ◽  
Vol 21 (9) ◽  
pp. S46
Author(s):  
Ram Haddas ◽  
Isador H. Lieberman ◽  
Donna D. Ohnmeiss ◽  
Ralph F. Rashbaum

PLoS ONE ◽  
2020 ◽  
Vol 15 (2) ◽  
pp. e0228306
Author(s):  
Peter A. Pahapill ◽  
Guangyu Chen ◽  
Elsa V. Arocho-Quinones ◽  
Andrew S. Nencka ◽  
Shi-Jiang Li

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment option for low back pain and radicular leg pain of failed back surgery syndrome (FBSS). In a recent study, high-frequency spinal cord stimulation (HFSCS) was found to be more effective in treating chronic pain than traditional paresthesia-based low-frequency SCS (paresthesia SCS). The purpose of this study is to evaluate the efficacy of paresthesia SCS and HFSCS in improving outcomes. METHODS We retrospectively reviewed the outcomes of patients who underwent paresthesia SCS or HFSCS between September 2016 and January 2019. Paresthesia SCS is generally characterized by programming stimulation parameters such that the patient experiences paresthesia, and the paresthesia topography overlaps the pain topography as much as possible. The patient in HFSCS had a placement of cylindrical lead at levels T9-10. Patients were programmed with the electrode overlying the inferior endplate of T9 (+) and the electrode overlying the superior endplate of T10 (–). RESULTS A total of 14 patients (4 males, 10 females) underwent paresthesia SCS implantation. Mean age was 77.2 ± 9.6 yr. A total of 5 patients (2 males, 3 females) underwent HFSCS implantation. Mean age was 78.2 ± 7.5 yr. Operative time was shorter for the HFSCS group compared to the paresthesia SCS group (53.4 ± 4.8 min vs 82.9 ± 20.3 min, respectively; P < .001). A total of 5 out of 5 patients in the HFSCS group (100%) and 10 out of 14 patients in the paresthesia SCS group (71.4%) achieved the outcome of 50% pain relief (P = .25) CONCLUSION To confirm paresthesia during the procedure in the elderly may be complicated by hearing/language difficulties or by sedative-related confusion. Compared to paresthesia SCS, HFSCS allows for lower operative times and a more efficient and accurate positioning of the electrodes.


2014 ◽  
Vol 33 (02) ◽  
pp. 119-124
Author(s):  
Isabela Palmeira Gomes ◽  
Otaviano Ottoni da Silva Netto ◽  
Rodrigo Almeida Matos ◽  
Ledismar José da Silva

ResumoEletrodos vêm sendo utilizados desde 1967 para estimulação da coluna espinal (em inglês, spinal cord stimulation – SCS) no tratamento de dor crônica refratária em uma série de distúrbios dolorosos, entre eles a síndrome do insucesso da cirurgia espinal (em inglês, failed-back surgery syndrome – FBSS), caracterizada por dor persistente após cirurgias de coluna, principalmente laminectomia. Neste artigo, apresenta-se uma revisão sistemática da literatura sobre o estudo da neuromodulação no tratamento da FBSS, utilizando-se as plataformas dos portais virtuais PubMed e MedLine, com o objetivo de levantar evidências que corroborem a eficácia e a segurança desse procedimento para dor crônica lombar decorrente de FBSS. A seleção dos estudos, publicados no período entre janeiro de 2003 e janeiro de 2013, envolveu critérios de análise de eficácia (melhora da dor, com redução de 50% ou mais, utilizando a Escala Visual Analógica – VAS – ou outras similares) e de segurança (quando complicações foram citadas). Foram inicialmente identificados 186 artigos, entre os quais nove foram selecionados por preencherem os critérios de inclusão/exclusão, totalizando 313 pacientes. Em todos os trabalhos selecionados, observou-se melhora considerável da dor após os procedimentos neuromodulatórios. Conclui-se que, quando bem indicada, a SCS é mais eficaz do que a reoperação ou qualquer outro tipo de terapia conservadora no tratamento de dor crônica lombossacral.


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