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1.
Neuromodulation ; 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38829295

ABSTRACT

OBJECTIVES: High-frequency spinal cord stimulation (10-kHz SCS) has been shown to be an effective treatment for refractory low back pain and neck pain with and without limb pain in clinical trial and real-world studies. However, limited information is available in the literature on the type and frequency of programming parameters required to optimize pain relief. MATERIALS AND METHODS: Retrospective trial and postimplant clinical and system device data were analyzed from consecutive patients with neck pain and low back pain, with and without limb pain, from a single clinical site, including both thoracic and cervical lead placement. Best bipole, stimulation parameters, and outcomes, including pain relief, change in opioid medication use, sleep, and daily function, were analyzed. RESULTS: Of the 92 patients in the trial, 70 received a permanent implant. Of these, the mean duration of follow-up was 1.8 ± 1.3 years. Pain relief of ≥50% at the last follow-up was achieved by 64% of patients implanted; in addition, 65% reduced their opioid medication use; 65% reported improved sleep, and 71% reported improved function. There was some consistency between the "best" bipole at trial and permanent implant, with 82% of patients within one bipole location, including 54% of permanent implants who were using the same best bipole as at trial. After permanent implant, device reprogramming was minimal, with ≤one reprogramming change per patient per quarter required to maintain pain outcomes. CONCLUSIONS: In the study, 10-kHz SCS was an effective therapy for treating chronic pain, whereby a high responder rate (≥50% pain relief) was achieved with short time to pain relief in trial and maintained with limited device programming after permanent implant. The data presented here provide insight into the programming required during the trial and implant stages to obtain and maintain therapeutic efficacy.

3.
Reg Anesth Pain Med ; 2024 May 31.
Article in English | MEDLINE | ID: mdl-38821539

ABSTRACT

BACKGROUND: Spinal cord stimulation (SCS) is an efficacious treatment for various refractory chronic pain syndromes. Serious complications including spinal cord compression (SCC) are rare with 19 previous reports which are mainly attributed to fibrotic scar tissue formation at the distal end of the leads at the location of the contacts. We report a case of SCC following SCS implantation at the lead entry location secondary to a delayed progression of spinal canal stenosis. CASE PRESENTATION: A patient in her early 70s underwent SCS implantation with adequate therapeutic benefit for approximately 2 years before citing complaints of increasing lower back pain and lower extremity radicular pain. Lumbar spine X-rays excluded lead migration as a causative factor. An MRI of the lumbar spine obtained 30 months following SCS implantation demonstrated a marked interval progression of central canal stenosis secondary to facet and ligamentous hypertrophy manifesting in compression of the spinal cord at the lead entry location. An L1-L2 decompressive laminectomy with hardware removal resulted in the resolution of her symptoms. A literature search conducted with the PubMed database identified previously published cases of SCC following SCS implantation which highlighted the rarity of this complication. CONCLUSION: Our case report urges physicians of SCS patients, noting a loss of therapeutic benefit with their device, to investigate new pathologies including SCC. Furthermore, our case highlights clinical symptoms and surgical treatments of SCC. Paddle leads are more commonly implicated in published cases of SCC than percutaneous leads. Lastly, MRI conditionality is critical to identifying cases of SCC.

4.
Reg Anesth Pain Med ; 2023 Nov 11.
Article in English | MEDLINE | ID: mdl-37951601

ABSTRACT

INTRODUCTION: Epidural steroid injections and epidural blood patches commonly involve the injection of a small amount of radiocontrast media under fluoroscopy to properly identify the target tissue or anatomic space and prevent off-target or intravascular delivery of therapeutic or diagnostic drugs. Iodinated low osmolar non-ionic contrast media is the standard preparation used as it is considered safe and cost-effective, but gadolinium-based preparations have been used as an alternative for patients with an 'iodine'-related or radiocontrast media allergy label to prevent hypersensitivity reactions. The risk of neurotoxic events when gadolinium is inadvertently injected into the intrathecal space has been reported in recent years, raising concerns when gadolinium-based contrast media is used in lieu of iodinated low osmolar non-ionic contrast media. METHODS: A retrospective review was conducted of patients who received gadolinium-based contrast media for procedures with risk of inadvertent intrathecal access from January 1, 2019 to May 1, 2022. Information on patient demographics, allergy label information, and procedure description was documented for all patients who received gadolinium-based contrast media for axial spine procedures (including epidural steroid injections, epidural blood patch procedures, and selective nerve root blocks), and all side effects reported within 1 month of the procedure were recorded. Saved fluoroscopy images of all procedures for which there was concern for possible gadolinium-based contrast media-related side effect were reviewed for evidence of inadvertent intrathecal gadolinium-based contrast media administration. Descriptive statistical analysis was performed using REDCap and IBM SPSS Statistics V.28. RESULTS: We identified 508 patients who received gadolinium-based contrast media during a fluoroscopically guided axial spine procedure. These patients underwent 697 epidural procedures and 23 patients were identified as experiencing an adverse event that could be consistent with possible, probable, or clear signs of exposure to intrathecal gadolinium. Our calculated adverse event rate was 3.3%. Ten patients required additional medical evaluation or treatment. DISCUSSION: Almost all patients in our cohort had an allergy label on their chart that guided the provider to switch to gadolinium-based contrast media, but most were incomplete, ill-defined, or related to allergy to iodine but not iodinated contrast media. Such practice is not recommended based on current guidelines. The current study raises concern regarding the use of gadolinium-based contrast media in axial spine procedures, with the risk of potential severe adverse events, without evidence-based need for avoiding iodinated contrast media.

5.
Reg Anesth Pain Med ; 2023 Sep 24.
Article in English | MEDLINE | ID: mdl-37748801

ABSTRACT

INTRODUCTION: Preclinical research demonstrated water-cooled radiofrequency (CRF) ablations have a significant impact on structural and functional changes compared to standard radiofrequency (SRF) ablations. Clinical procedures utilizing RF to treat chronic pain conditions also show sustained functional outcomes. We hypothesize that the design of the RF probes plays an important role in interventional procedure success, but it remains unclear which specific design features. METHODS: RF ablations were performed in male Lewis rats (n=51) using multiple-sized probes for CRF (17 Ga/2 mm and 17Ga/4 mm) and SRF (22Ga/5 mm, 18Ga/10 mm and 16Ga/10 mm) to evaluate generator energy output, lesion length, axon damage by histology and nerve function analysis via electromyography. To exclude probe design variables beyond size and remain objective, we tested cooled probes with and without water circulation, which resulted in the CRF probe performing like an SRF probe. RESULTS: Consistent with our previous findings in smaller probes, CRF large probes delivered more energy (p<0.01) and generated multiple zones of thermal damage in sciatic nerves. When the water-circulating feature was turned off, however, energy output (p<0.001) and lesion length (p<0.05) was significantly reduced. CRF probes with the water circulation also featured significantly more axonal disruption, than larger sized SRF probes (p<0.0001). CONCLUSIONS: Overall, this data confirms that CRF's water-circulating technology has a greater impact on energy deposition, lesion length and axon damage compared with SRF ablations. Moreover, results suggest that the structural differences between RF modalities cannot be solely attributed to probe size, and it may shed light on its differences in clinical outcomes.

6.
Neuromodulation ; 26(7): 1400-1411, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37589641

ABSTRACT

OBJECTIVE: This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. MATERIALS AND METHODS: This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. RESULTS: A total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial. CONCLUSIONS: Multiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03594266.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Humans , Spinal Cord Stimulation/adverse effects , Spinal Cord Stimulation/methods , Chronic Pain/diagnosis , Chronic Pain/therapy , Leg , Prospective Studies , Single-Blind Method , Treatment Outcome , Spinal Cord
8.
Reg Anesth Pain Med ; 48(6): 288-295, 2023 06.
Article in English | MEDLINE | ID: mdl-37080579

ABSTRACT

The treatment options for patients with chronic pain conditions are impacted by recent research, patient needs, and insurance coverage. Although various factors affect the cost of healthcare, the economic burden on the patient and the healthcare system must be considered when choosing the appropriate treatments for each patient. This Daring Discourse aims to review and further clarify existing economic evaluations and thus examine cost-effectiveness with regards to neuromodulation for the treatment of persistent spinal pain syndrome and complex regional pain syndrome. Specific consideration is given to spinal cord stimulation, as it is a widely studied and implemented neuromodulation modality for the treatment of these debilitating conditions.


Subject(s)
Chronic Pain , Complex Regional Pain Syndromes , Spinal Cord Stimulation , Humans , Complex Regional Pain Syndromes/diagnosis , Complex Regional Pain Syndromes/therapy , Pain , Pain Management , Chronic Pain/diagnosis , Chronic Pain/therapy , Treatment Outcome
9.
Reg Anesth Pain Med ; 48(6): 251-272, 2023 06.
Article in English | MEDLINE | ID: mdl-37001887

ABSTRACT

BACKGROUND/IMPORTANCE: Patient selection for spinal cord stimulation (SCS) therapy is crucial and is traditionally performed with clinical selection followed by a screening trial. The factors influencing patient selection and the importance of trialing have not been systematically evaluated. OBJECTIVE: We report a narrative review conducted to synthesize evidence regarding patient selection and the role of SCS trials. EVIDENCE REVIEW: Medline, EMBASE and Cochrane databases were searched for reports (any design) of SCS in adult patients, from their inception until March 30, 2022. Study selection and data extraction were carried out using DistillerSR. Data were organized into tables and narrative summaries, categorized by study design. Importance of patient variables and trialing was considered by looking at their influence on the long-term therapy success. FINDINGS: Among 7321 citations, 201 reports consisting of 60 systematic reviews, 36 randomized controlled trials (RCTs), 41 observational studies (OSs), 51 registry-based reports, and 13 case reports on complications during trialing were included. Based on RCTs and OSs, the median trial success rate was 72% and 82%, and therapy success was 65% and 61% at 12 months, respectively. Although several psychological and non-psychological determinants have been investigated, studies do not report a consistent approach to patient selection. Among psychological factors, untreated depression was associated with poor long-term outcomes, but the effect of others was inconsistent. Most RCTs except for chronic angina involved trialing and only one RCT compared patient selection with or without trial. The median (range) trial duration was 10 (0-30) and 7 (0-56) days among RCTs and OSs, respectively. CONCLUSIONS: Due to lack of a consistent approach to identify responders for SCS therapy, trialing complements patient selection to exclude patients who do not find the therapy helpful and/or intolerant of the SCS system. However, more rigorous and large studies are necessary to better evaluate its role.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Adult , Humans , Spinal Cord Stimulation/adverse effects , Patient Selection , Pain Management , Chronic Pain/diagnosis , Chronic Pain/therapy , Research Design , Spinal Cord
10.
Reg Anesth Pain Med ; 48(6): 273-287, 2023 06.
Article in English | MEDLINE | ID: mdl-37001888

ABSTRACT

Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized for this therapy; however, the prognostic capabilities and deployment strategies of existing selection techniques, including an SCS trial, have been questioned. After approval by the Board of Directors of the American Society of Regional Anesthesia and Pain Medicine, a steering committee was formed to develop evidence-based guidelines for patient selection and the role of an SCS trial. Representatives of professional organizations with clinical expertize were invited to participate as committee members. A comprehensive literature review was carried out by the steering committee, and the results organized into narrative reports, which were circulated to all the committee members. Individual statements and recommendations within each of seven sections were formulated by the steering committee and circulated to members for voting. We used a modified Delphi method wherein drafts were circulated to each member in a blinded fashion for voting. Comments were incorporated in the subsequent revisions, which were recirculated for voting to achieve consensus. Seven sections with a total of 39 recommendations were approved with 100% consensus from all the members. Sections included definitions and terminology of SCS trial; benefits of SCS trial; screening for psychosocial characteristics; patient perceptions on SCS therapy and the use of trial; other patient predictors of SCS therapy; conduct of SCS trials; and evaluation of SCS trials including minimum criteria for success. Recommendations included that SCS trial should be performed before a definitive SCS implant except in anginal pain (grade B). All patients must be screened with an objective validated instrument for psychosocial factors, and this must include depression (grade B). Despite some limitations, a trial helps patient selection and provides patients with an opportunity to experience the therapy. These recommendations are expected to guide practicing physicians and other stakeholders and should not be mistaken as practice standards. Physicians should continue to make their best judgment based on individual patient considerations and preferences.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Humans , Chronic Pain/diagnosis , Chronic Pain/therapy , Spinal Cord Stimulation/methods , Analgesics, Opioid , Patient Selection , Pain Management/methods , Spinal Cord , Treatment Outcome
11.
Neuromodulation ; 26(5): 1089-1094, 2023 Jul.
Article in English | MEDLINE | ID: mdl-35690512

ABSTRACT

OBJECTIVES: To determine the prevalence of Staphylococcus aureus (S aureus) colonization for spinal cord stimulation (SCS) surgical patients and to identify specific at-risk patient populations. MATERIALS AND METHODS: Following Institutional Review Board approval, a retrospective review identified 232 SCS surgical patients. Preoperative Saureus nasal swab results were reviewed. Preoperative characteristics that included age at the time of procedure, body mass index, and medical comorbidities including, but not limited to, diabetes, smoking, obesity, and a history of surgical site infections were identified for each patient. The Clopper-Pearson method was used to calculate 95% CIs for proportions, and Fisher exact tests were used to estimate odds ratios (95% CI) for patient characteristics. RESULTS: The 232 SCS surgical patients who were identified underwent 396 unique neuromodulation procedures, with 100% screened for methicillin-resistant Saureus (MRSA) and 98.3% screened for methicillin-sensitive Saureus (MSSA). Overall, 23.3% (n = 54/232, 95% CI: 18.0%-29.3%) of patients were preoperatively colonized with Saureus, according to the following classification: 4.3% (n = 10/232, 95% CI: 2.1%-7.8%) were positive for MRSA and 20.2% (n = 46/228, 95% CI: 15.2%-26.0%) were positive for MSSA. Two patients were colonized with both MRSA and MSSA. Furthermore, 95.7% (n = 44/46, 95% CI: 85.2%-99.5%) of patients that were MSSA colonized were MRSA negative. Analysis of independent patient characteristics revealed anxiety and hypothyroidism as the only conditions associated with significantly increased odds of MRSA and MSSA colonization, respectively. CONCLUSIONS: Staphylococcusaureus colonization was present in >20% of SCS patients, with MSSA carriage occurring at a rate nearly five times that of MRSA. MRSA screening alone would not have identified >90% of Saureus-colonized patients with only MSSA carrier status. Therefore, consideration should be given to preoperative screening for both MRSA and MSSA. Since limited patient characteristics were associated with greater risk for Saureus colonization, all patient populations should be screened.


Subject(s)
Methicillin-Resistant Staphylococcus aureus , Staphylococcal Infections , Humans , Staphylococcus aureus , Prevalence , Staphylococcal Infections/diagnosis , Staphylococcal Infections/epidemiology , Methicillin , Spinal Cord
12.
Pain Pract ; 23(3): 301-312, 2023 03.
Article in English | MEDLINE | ID: mdl-36409060

ABSTRACT

INTRODUCTION: Traditional spinal cord stimulation (t-SCS) has been used to treat chronic pain for over 50 years. However, up to 30% of patients undergo explant, with the main indication being loss of efficacy (LoE), and few alternative treatment options exist for these patients. Strategies to mitigate LoE commonly include conversion to another type of SCS (termed 'salvage' or 'rescue'). This review summarizes the existing literature concerning the efficacy and safety of 10 kHz SCS as a salvage therapy. METHODS: We searched PubMed, the Cochrane Library, ClinicalTrials.gov, and other sources between January 2009 and April 2021. Records were retained if the authors reported clinical outcomes with a minimum of ≥ 3 months of follow-up in patients implanted with a Senza® 10 kHz SCS system in an effort to treat t-SCS LoE. RESULTS: Ten articles were eligible for inclusion, reporting 3 prospective studies and 7 retrospective reviews. In the single study that salvaged patients without a repeat trial prior to surgery, 81% of patients were responders (≥ 50% pain relief from baseline), with mean pain relief of 60%. Among repeat-trial studies, the responder rate ranged from 46% to 80%, and mean pain relief from 47% to 68%. No unanticipated therapy-related safety issues were reported among the included articles. CONCLUSION: Preliminary data suggest that chronic back and/or leg pain patients with t-SCS LoE can experience improved and durable pain relief after conversion to 10 kHz SCS. However, additional research is needed to define predictors of success and establish whether salvage without a repeat trial is a viable conversion method.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Humans , Spinal Cord Stimulation/methods , Salvage Therapy , Retrospective Studies , Prospective Studies , Chronic Pain/therapy , Treatment Outcome , Spinal Cord
15.
Pain Physician ; 25(5): 387-390, 2022 08.
Article in English | MEDLINE | ID: mdl-35901479

ABSTRACT

BACKGROUND: The COVID-19 pandemic resulted in a novel challenge for healthcare delivery and implementation in the United States (US) in 2020 and beyond. Telemedicine arose as a significant and effective medium for safe and efficacious physician-patient interactions. Prior to the COVID-19 pandemic, telemedicine while available, had infrequently been utilized in pain medicine practices due to difficulties with reimbursement, the learning curve associated with new technology usage, and the need for new logistical systems in place to implement telemedicine effectively. Given the unique constraints on the healthcare system during the COVID-19 pandemic, the ubiquitous utilization of telemedicine among pain medicine physicians increased, giving insight into potential future roles for the technology beyond the pandemic. OBJECTIVES: To survey and understand the state of implementation of telemedicine into pain medicine practices across practice settings and geographical areas; to identify potential barriers to the implementation of telemedicine in pain medicine practice; and to identify the likelihood of telemedicine continuing beyond the pandemic in pain medicine practice. STUDY DESIGN: Online questionnaire targeting Pain Medicine physicians in the US. Participants were asked questions related to the use of telemedicine during the first peak of the COVID-19 pandemic. SETTING: Online-based questionnaire distributed to academic and private practice pain medicine physicians nationally in the United States. METHODS: A 34 web-based questionnaires were distributed by the American Society of Regional Anesthesia and Pain Medicine and the Spine Intervention Society to all active members. Data were analyzed using SAS v9.4. RESULTS: Between December 3, 2020, and February 18, 2021, 164 participants accessed the survey with a response rate of 14.3%. Overall, academic physicians were more likely to implement telemedicine than private practice physicians. Telemedicine was also more frequently utilized for follow-up appointments rather than initial visits. LIMITATIONS: Although our n = 164, the overall low response rate of 14.3% warrants further investigation into the utilization of telemedicine throughout the COVID-19 pandemic. CONCLUSIONS: Telemedicine as an emerging technology for efficient communication played a key role in mitigating the adverse effects of the COVID -19 pandemic on chronic pain patients. The utilization of telemedicine remarkably increased after the start of the pandemic within 1 to 2 weeks. Overall, private hospital-based centers were significantly less likely to implement telemedicine than academic centers, possibly due to limited access to secure telemedicine platforms and high start-up costs. Telemedicine was used more frequently for follow-up visits than initial visit encounters at most centers. In spite of the unforeseen consequences to the healthcare system and chronic pain practices in the US from COVID-19, telehealth has emerged as a unique model of care for patients with chronic pain. Although it has flaws, telehealth has the ability to increase access to care beyond the end of the pandemic. Further identification of barriers to the use of telemedicine platforms in private practices should be addressed from a policy perspective to facilitate increased care access.


Subject(s)
COVID-19 , Chronic Pain , Telemedicine , Analgesics , Humans , Pandemics , SARS-CoV-2 , Surveys and Questionnaires , Telemedicine/methods , United States
16.
Reg Anesth Pain Med ; 47(9): 511-518, 2022 09.
Article in English | MEDLINE | ID: mdl-35715014

ABSTRACT

The medical field has been experiencing numerous drug shortages in recent years. The most recent shortage to impact the field of interventional pain medicine is that of iodinated contrast medium. Pain physicians must adapt to these changes while maintaining quality of care. This position statement offers guidance on adapting to the shortage.


Subject(s)
Anesthesia, Conduction , Physicians , Humans , Pain , Pain Management , Societies, Medical , United States
17.
Neuromodulation ; 25(1): 35-52, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35041587

ABSTRACT

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based upon their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.


Subject(s)
Electric Stimulation Therapy , Consensus , Humans
18.
Pain Med ; 23(1): 152-163, 2022 01 03.
Article in English | MEDLINE | ID: mdl-34601597

ABSTRACT

OBJECTIVE: This study was designed to assess whether using pulse dosing (PD) (regularly cycled intermittent stimulation) of high-frequency 10-kHz spinal cord stimulation (10-kHz SCS) can reduce device recharge time while maintaining efficacy in patients with chronic intractable back pain with or without leg pain. DESIGN: Prospective, multicenter, observational study. METHODS: Patients successfully using 10-kHz SCS at 100%ON (i.e., continuously with no PD) for >3 months were consecutively enrolled. After a 1-week baseline period of documenting their pain twice daily on a 0-10 numerical rating scale (NRS) using 100%ON of their "favorite" program, all subjects were reprogrammed to 14%PD for 10-14 days. If subjects preferred 14%PD to 100%ON, they were programmed to 3%PD; otherwise, they were programmed to 50%PD. Subjects used this next program for another 10-14 days. Subjects then entered a 3-month observational period during which they were requested to use but not limited to their most preferred %PD program. Toward the end of 3 months, subjects completed a 7-day NRS diary and indicated a final %PD program preference. Study endpoints included %PD preference, mean diary NRS by %PD, and daily minutes and patterns of charging. RESULTS: Of 31 subjects completing the study, 81% preferred less than 100%ON. Among the subjects, 39% preferred 3%PD, 32% preferred 14%PD, 10% preferred 50%PD, and 19% preferred 100%ON. Average daily charge durations were 8.3 ± 3.1 minutes for 3%PD, 13.9 ± 4.9 minutes for 14%PD, 26.2 ± 7.4 minutes for 50%PD, and 43.8 ± 10.9 minutes for 100%ON. Regression modeling suggested that pain relief was weighted as more than twice as influential as charging in preference for reduced %PD. CONCLUSIONS: This prospective study suggests that 10-kHz SCS therapy with PD may be successfully used in a large majority of 10-kHz SCS responders, maintaining efficacy while reducing device charging time by nearly two thirds.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Chronic Pain/therapy , Humans , Pain Management , Paresthesia , Prospective Studies
19.
Reg Anesth Pain Med ; 47(1): 3-59, 2022 01.
Article in English | MEDLINE | ID: mdl-34764220

ABSTRACT

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.


Subject(s)
Neck Pain , Zygapophyseal Joint , Arthralgia , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/surgery , Humans , Injections, Intra-Articular , Zygapophyseal Joint/diagnostic imaging , Zygapophyseal Joint/surgery
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