Rescue therapy with novel waveform spinal cord stimulation for patients with failed back surgery syndrome refractory to conventional stimulation: a systematic review and meta-analysis
OBJECTIVE Conventional spinal cord stimulators (SCSs) have demonstrated efficacy in individuals with failed back surgery syndrome (FBSS). However, a subgroup of patients may become refractory to the effects of conventional waveforms over time. The objective of this study was to systematically review and evaluate the current literature on the use of novel waveform spinal cord stimulation for the management of FBSS refractory to conventional SCSs. METHODS A comprehensive electronic search of the literature published in electronic databases, including Ovid MEDLINE and Epub Ahead of Print, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus, was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The outcomes of interest were reduction in back pain and/or leg pain after conversion from conventional to novel SCSs. Risk of bias was assessed with the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria. RESULTS A total of 6 studies with 137 patients with FBSS were identified. Studies were published between 2013 and 2021. The mean ± SD age of the pooled patient sample was 55 ± 10.5 years. All patients who underwent treatment with conventional SCSs were identified. Two studies evaluated the efficacy of high-density spinal cord stimulation, 3 studies evaluated burst spinal cord stimulation, and 1 study assessed multimodal waveforms. The mean difference in back pain scores after conversion from a standard SCS to a novel waveform SCS was 2.55 (95% CI 1.59–4.08), demonstrating a significant reduction in back pain after conversion to novel stimulation. The authors also performed a subgroup analysis to compare burst stimulation to tonic waveforms. In this analysis, the authors found no significant difference in the average reductions in back pain between the 2 groups (p = 0.534).The authors found an I2 statistic equivalent to 98.47% in the meta-regression model used to assess the effect of follow-up duration on study outcome; this value implied that the variability in the data can be attributed to the remaining between-study heterogeneity. The overall certainty was moderate, with a high risk of bias across studies. CONCLUSIONS Rescue therapy with novel waveform spinal cord stimulation is a potential option for pain reduction in patients who become refractory to conventional SCSs. Conversion to novel waveform SCSs may potentially mitigate expenses and complications.
Ultrasound-guided lumbar medial branch blocks and intra-articular facet joint injections: a systematic review and meta-analysis
Abstract There is great interest in expanding the use of ultrasound (US), but new challenges exist with its application to lumbar facet–targeted procedures. The primary aim of this systematic review and meta-analysis was to determine the risk of incorrect needle placement associated with US–guided lumbar medial branch blocks (MBB) and facet joint injections (FJI) as confirmed by fluoroscopy or computerized tomography (CT). An a priori protocol was registered, and a database search was conducted. Inclusion criteria included all study types. Risk of bias was assessed using the Cochrane risk of bias tool for randomized controlled trials and the National Heart, Lung, and Blood tool for assessing risk bias for observational cohort studies. Pooled analysis of the risk difference (RD) of incorrect needle placement was calculated. Pooled analysis of 7 studies demonstrated an 11% RD (P < 0.0009) of incorrect needle placement for US-guided MBB confirmed using fluoroscopy with and without contrast. Pooled analysis of 3 studies demonstrated a 13% RD (P < 0.0001) of incorrect needle placement for US-guided FJI confirmed using CT. The time to complete a single-level MBB ranged from 2.6 to 5.0 minutes. The certainty of evidence was low to very low. Ultrasound-guided lumbar MBB and FJI are associated with a significant risk of incorrect needle placement when confirmed by fluoroscopy or CT. The technical limitations of US and individual patient factors could contribute to the risk of incorrect needle placement.
Injectable Biologics for Neuropathic Pain: A Systematic Review
Abstract Background Neuropathic pain is a complex condition that can be refractory to conventional management and can cause persistent suffering in patients. Current pharmacologic treatments can provide temporary symptomatic relief; however, the mechanism of these therapies does not address the underlying cause of neuropathic pain. The use of injectable biologics for neuropathic pain has multiple proposed mechanisms for analgesia including attenuation of inflammatory mediated processes, arrest or delay of the degenerative process, inhibition of apoptotic pathways, and augmentation of the survival and recovery of injured and uninjured nerves. Study Design A systematic review of human studies involving the use of injectable biologics for neuropathic pain. Methods A comprehensive search of several data bases including Ovid MEDLINE ® and Epub Ahead of Print, In Process & Other Non-Indexed Citations and Daily, and Ovid Embase from inception to November 24, 2020. Results The initial search yielded 3,450 studies with an additional 6 studies identified through other resources. Twenty-seven studies were included after independent review by two of the investigators. The included studies assessed the efficacy of injectable biologics for the treatment of neuropathic pain defined as pain reduction. Secondary outcome measures included functional improvement as well as safety of the procedures. A qualitative assessment of the literature without meta-analysis was performed due to the heterogeneity of the data. Conclusion According to the GRADE criteria, there is very low certainty of evidence in support of the efficacy of injectable biologics for treatment of neuropathic pain. Future efforts should focus on creating a standardized methodology and study design with respect to preparation, dosage and route of administration of biologics. This will serve as a catalyst for higher quality randomized trials with generation of more useful data to help drive informed clinical decision making.
Product characteristics should be reported in all biological therapy publications
Abstract Spinal cord stimulation (SCS) is used to treat a variety of chronic pain conditions refractory to more conservative management including refractory angina pectoris. We identified 31 patients who underwent SCS implantation for the indication of refractory angina at a single institution from 2003 through 2018. Sixteen patients were male, and 15 were female. Average age was 53.9 years. Prior to SCS implantation, all patients had at least one coronary angiogram. Ten (32.3%) patients had undergone percutaneous coronary intervention, and four (12.9%) had undergone coronary artery bypass grafting. Thirty patients (96.7%) were currently using anti-angina medications. Twenty-six patients (83.9%) were on antiplatelet or anticoagulant agents at the time of SCS evaluation. Spinal cord stimulation implanters must perform a comprehensive evaluation incorporating appropriate multidisciplinary care particularly in patients with refractory angina given their cardiovascular comorbidities. It is important to have baseline data (e.g., pain scores, nitroglycerin consumption, frequency of angina episodes, and a questionnaire, such as the Seattle Angina Questionnaire) to compare with follow-up data to help define treatment success. We report a single institution’s pre-operative experience for patients undergoing SCS for refractory angina to illustrate unique pre-operative SCS considerations in this chronic pain population.
Prevalence of chronic pain after spinal cord injury: a systematic review and meta-analysis
Background The reported prevalence of chronic pain after spinal cord injury (SCI) varies widely due, in part, to differences in the taxonomy of chronic pain. A widely used classification system is available to describe subcategories of chronic pain in SCI, but the prevalence of chronic pain in SCI based on this system is unknown. Objective The primary objective of this systematic review and meta-analysis is to determine the prevalence of chronic pain after SCI based on the International Spinal Cord Injury Pain (ISCIP) classification system. Evidence review A comprehensive search of databases from January 1980 to August 2019 was conducted. The risk of bias was assessed using a modified tool developed for uncontrolled studies. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess certainty in prevalence estimates. Findings A total of 1305 records were screened, and 37 studies met inclusion criteria. The pooled prevalence of overall chronic pain was 68% (95% CI 63% to 73%). The pooled prevalence of neuropathic pain in 13 studies was 58% (95% CI 49% to 68%); the pooled prevalence of musculoskeletal pain in 11 studies was 56% (95% CI 41% to 70%); the pooled prevalence of visceral pain in 8 studies was 20% (95% CI 11% to 29%) and the pooled prevalence of nociceptive pain in 2 studies was 45% (95% CI 13% to 78%). Meta-regression of risk of bias (p=0.20), traumatic versus non-traumatic etiology of injury (p=0.59), and studies where pain was a primary outcome (p=0.32) demonstrated that these factors were not significant moderators of heterogeneity. Certainty in prevalence estimates was judged to be low due to unexplained heterogeneity. Conclusion This systematic review and meta-analysis extends the findings of previous studies by reporting the prevalence of chronic pain after SCI based on the ISCIP classification system, thereby reducing clinical heterogeneity in the reporting of pain prevalence related to SCI.
The Use of the Seattle Angina Questionnaire in Patients Who Underwent Spinal Cord Stimulation for Refractory Angina Pectoris
Abstract Background The Seattle Angina Questionnaire (SAQ) is a self-administered questionnaire used in cardiac patients to quantify angina based on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. Here we report the use of the SAQ to assess angina symptoms in 18 patients who underwent spinal cord stimulation (SCS) for refractory angina pectoris (RAP) at the Mayo Clinic. Methods Electronic health records were searched to find patients who underwent SCS for the treatment of RAP at a single institution from 2003 to 2018. Eligible patients were asked to participate in a phone survey that included the SAQ. Results Out of 13 patients who still had their implant, six (46%) had minimal physical limitations. Ten patients (76.9%) had favorable anginal frequency scores, defined as minimal or mild. Out of the five patients who had their device removed, one (20%) had minimal physical limitations and three (60%) had favorable anginal frequency scores. There was a high treatment satisfaction score for both those with their implant in place and those with the device removed. Conclusion The SAQ is useful as a comprehensive measure specific to patients with RAP assessing function, pain, and satisfaction. The utilization of this tool pre- and post-operatively may provide additional information to analyze the effectiveness of SCS for RAP.
Beyond Revision Surgery: Work‐Up and Interventional Treatments for the Painful Total Knee Arthroplasty
AbstractTotal knee arthroplasty is a common and successful treatment modality for knee arthritis that is refractory to conservative management strategies. Over 600,000 arthroplasties are performed per year in the United States, and this number is expected to increase in the coming years. Unfortunately, 8% to 34% of patients experience chronic pain after having a total knee arthroplasty. These patients should undergo an appropriate work‐up by the orthopedic surgeon, but many times a surgical problem is not uncovered. In these situations, a thorough and specific plan for pain management should be sought. In this article, we outline the work‐up of a painful total knee arthroplasty. Then we provide a thorough review of interventional pain management strategies and highlight the pertinent literature. Lastly, we hypothesize future developments in the field that may provide better outcomes for patients suffering from painful total knee arthroplasty.