Publications by authors named "Dawood Sayed"

38 Publications

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the Procedure: Interim 6-Month Report of a Randomized Controlled Trial.

J Pain Res 2021 10;14:1687-1697. Epub 2021 Jun 10.

The University of Kansas Medical Center, Kansas City, KS, USA.

Background: Lumbar spinal stenosis (LSS) is a serious degenerative condition of the spine that can cause significant functional disability. Therapies for these patients generally begin with conservative management, since more invasive interventions such as open surgery and spinal implants are associated with higher complication rates. Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy. This composite first-line treatment plan may include conservative care together with early interventional treatment options such as epidural steroid injections, radiofrequency ablation and the Procedure.

Methods: This prospective randomized controlled trial evaluates patients aged 50 to 80 years treated with plus CMM, compared to those treated with CMM alone, as the active control. Walking tolerance test outcomes and incidence of subsequent disallowed procedures provided objective real-world outcome data. The incidence of device or procedure-related adverse events was analyzed. Follow-up includes 6-month, 1-year and 2-year assessments, with 1-year being primary. Patients in the +CMM group are followed at 3, 4, and 5 years. This is a report of interim 6-month outcomes.

Results: Of 155 patients enrolled at 19 US interventional pain management centers, 78 were allocated to CMM-Alone, and 77 to +CMM. At 6-months, the validated walking tolerance test demonstrated statistical superiority of +CMM versus CMM-Alone (p<0.001). The incidence of patients receiving a subsequent disallowed procedure, and thereby considered treatment failures in their study group, was statistically significantly higher in CMM-Alone versus +CMM (p<0.001). There were no device or procedure-related adverse events in either group.

Conclusion: At 6-months, the Procedure combined with CMM provided statistically superior objective real-world outcomes versus CMM-Alone. There were no device or procedure-related adverse events reported in either study group. With its excellent safety profile and superior efficacy, is uniquely positioned as early first-line therapy.
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http://dx.doi.org/10.2147/JPR.S312573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203201PMC
June 2021

Persistent Spinal Pain Syndrome: New Terminology for a New Era.

J Pain Res 2021 8;14:1627-1630. Epub 2021 Jun 8.

Spine and Nerve Center of the Virginias, Charleston, WV, USA.

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http://dx.doi.org/10.2147/JPR.S320923DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197591PMC
June 2021

Review of Current Evidence for Minimally Invasive Posterior Sacroiliac Joint Fusion.

Int J Spine Surg 2021 Jun 7;15(3):514-524. Epub 2021 May 7.

Department of Anesthesiology, University of Kansas Medical Center, Kansas City, Kansas.

The sacroiliac joint (SIJ) is a large, irregularly shaped, serpentine joint structure bordered anteriorly and posteriorly by the sacroiliac ligaments. With increased recognition of the SIJ as a pain source, treatments have been historically nonsurgical in nature. Common treatments include bracing, medications, activity modification, manual therapy, chiropractic manipulation, physical therapy, and intra-articular SIJ injections. Surgical stabilization and/or fusion of the SIJ may be considered when a patient has persistent moderate to severe pain, functional impairment, and failed conservative management. Surgical stabilization and fusion has traditionally been by way of the transiliac approach. More recent SIJ fusion systems have proposed not only a posterior approach but one that stabilizes the joint space by placing an allograft within the SIJ. Anatomically, a posterior approach is able to avoid neurovascular structures that otherwise are encountered with the transiliac approach and may be performed percutaneously. Preliminary evidence reports consistent pain reduction with minimal complications. This paper is purposed to detail the present evidence of minimally invasive posterior SIJ fusion, as well as highlight the need for further research moving forward.
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http://dx.doi.org/10.14444/8073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176825PMC
June 2021

The American Society of Pain and Neuroscience (ASPN) Practical Guidelines to Study Design and Scientific Manuscript Preparation in Neuromodulation.

J Pain Res 2021 16;14:1027-1041. Epub 2021 Apr 16.

The Spine and Nerve Center of the Virginias, Charleston, WV, USA.

Background: Healthcare clinical and even policy decisions are progressively made based on research-based evidence. The process by which the appropriate trials are developed and well-written manuscripts by means of evidence-based medicine recommendations has resulted in unprecedented necessity in evidence-based medicine in neuromodulation.

Methods: The essential considerations in the planning of neuromodulation research are discussed in the light of available scientific literature as well as the authors' scientific expertise regarding research study design and scientific manuscript preparation.

Conclusion: This article should enable the reader to understand how to appropriately design a clinical research study and prepare scientific manuscripts. The high-quality and well-designed studies, when performed and reported effectively, support evidence-based medicine and foster improved patient outcomes.
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http://dx.doi.org/10.2147/JPR.S295502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057952PMC
April 2021

Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial.

JAMA Neurol 2021 Jun;78(6):687-698

Coastal Orthopedics and Sports Medicine, Bradenton, Florida.

Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.

Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).

Design, Setting, And Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.

Interventions: Implanted medical device delivering 10-kHz SCS.

Main Outcomes And Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.

Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).

Conclusions And Relevance: Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN.

Trial Registration: ClincalTrials.gov Identifier: NCT03228420.
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http://dx.doi.org/10.1001/jamaneurol.2021.0538DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022268PMC
June 2021

Recommendations and Guidance for Steroid Injection Therapy and COVID-19 Vaccine Administration from the American Society of Pain and Neuroscience (ASPN).

J Pain Res 2021 5;14:623-629. Epub 2021 Mar 5.

Department of Pain Medicine, The Spine and Nerve Center of the Virginias, Charleston, WV, USA.

To date, COVID-19 has spread to more than 108 million people globally, with a death toll surpassing 2 1/2 million. With the United States Food and Drug Administration (FDA) approval of two highly effective COVID-19 vaccines from Pfizer-BioNtech and Moderna, we now have a novel approach to contain COVID-19 related morbidity and mortality. Chronic pain care has faced unprecedented challenges for patients and providers in this ever-changing climate. With the approval of COVID-19 vaccines, we now face questions relating to the potential effects of pain treatments utilizing steroids on vaccine efficacy. In this analysis, we address these issues and provide guidance for steroid therapies based on available data and expert recommendations.
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http://dx.doi.org/10.2147/JPR.S302115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944369PMC
March 2021

Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months.

Neuromodulation 2021 Apr 19;24(3):499-506. Epub 2021 Jan 19.

Southwest Spine & Pain Center, Provo, UT, USA.

Objectives: High-frequency 10 kHz spinal cord stimulation (10 kHz-SCS) has achieved analgesia superior to traditional SCS in a number of studies. However, there is concern regarding long-term outcomes of 10 kHz-SCS. Prior work has suggested that explant rates are higher with 10 kHz-SCS. Our primary objective was to determine the explant rate of 10 kHz-SCS in a large patient cohort from multiple centers followed for at least 12 months after implant surgery.

Materials And Methods: We performed a retrospective chart review of all patients who received a 10 kHz-SCS implant before July 1, 2019. We abstracted patient demographics, implant date, primary site of pain, implant indication, explant date, and reason for explant. A total of 744 patients were included in the study analysis.

Results: Average age of the overall cohort was 65.53 years and 407 (54.7%) were women. Average follow-up for all patients was 793 days. There were a total of 76 explants (10.2%). The most common reason for explant was loss of efficacy, which accounted for 39 explants (51.3% of total explants, 5.2% of overall cohort). Female sex and radiculopathy as the SCS indication were associated with statistically significant decreased risk of 10 kHz-SCS explant.

Conclusions: We found 10 kHz-SCS explant rates to be similar to prior reported explant rates for traditional SCS devices. Patient-related factors including female sex and radiculopathy as the primary SCS indication may be protective factors against explantation.
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http://dx.doi.org/10.1111/ner.13359DOI Listing
April 2021

A Review and Algorithm in the Diagnosis and Treatment of Sacroiliac Joint Pain.

J Pain Res 2020 8;13:3337-3348. Epub 2020 Dec 8.

Pain Specialists of America, Austin, TX, USA.

Introduction: The sacroiliac joint (SIJ) has been estimated to contribute to pain in as much as 38% of cases of lower back pain. There are no clear diagnostic or treatment pathways. This article seeks to establish a clearer pathway and algorithm for treating patients.

Methods: The literature was reviewed in order to review the biomechanics, as well as establish the various diagnostic and treatment options. Diagnostic factors addressed include etiology, history, physical exam, and imaging studies. Treatment options reviewed include conservative measures, as well as interventional and surgical options.

Results: Proposed criteria for diagnosis of sacroiliac joint dysfunction can include pain in the area of the sacroiliac joint, reproducible pain with provocative maneuvers, and pain relief with a local anesthetic injection into the SIJ. Conventional non-surgical therapies such as medications, physical therapy, radiofrequency denervation, and direct SI joint injections may have some limited durability in therapeutic benefit. Surgical fixation can be by a lateral or posterior/posterior oblique approach with the literature supporting minimally invasive options for improving pain and function and maintaining a low adverse event profile.

Conclusion: SIJ pain is felt to be an underdiagnosed and undertreated element of LBP. There is an emerging disconnect between the growing incidence of diagnosed SI pathology and underwhelming treatment efficacy of medical treatment. This has led to an increase in SI joint fixation. We have created a clearer diagnostic and treatment pathway to establish an algorithm for patients that can include conservative measures and interventional techniques once the diagnosis is identified.
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http://dx.doi.org/10.2147/JPR.S279390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737553PMC
December 2020

Failure of SCS MR-Conditional Modes Due to High Impedance: A Review of Literature and Case Series.

Pain Ther 2021 Jun 21;10(1):729-737. Epub 2020 Nov 21.

Anesthesiology, NewYork-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.

Introduction: Magnetic resonance imaging (MRI) conditional modes are a novel feature for certain Food and Drug Administration (FDA)-approved spinal cord stimulation (SCS) devices. However, there is a paucity of literature around the limitation of MRI-conditional modes ("MRI safe"), specifically in clinical scenarios where urgent MRIs may be needed. One such limitation is load impedance, referring to the circuit's resistance to the current being generated by the system. High impedance can limit the MRI-conditional mode capability, presenting potential harm to a patient undergoing an MRI or make an MRI unable to be completed.

Methods: Three cases were identified, and informed consent was obtained. All information was obtained via retrospective chart review.

Results: In this case series of three patients where MRI-conditional SCS systems were unable to be placed in "MRI safe" settings, preventing timely MRI study completion in the setting of high impedance, all three were required to undergo alternative imaging including CT scans, and two patients ultimately had the system explanted and one chose to be re-implanted after completion of scans.

Conclusion: This case series highlights the need for further investigation of impedance in SCS systems and potential limitations for future MRI usage. The review of literature of impedance in SCS shows both device- and physiologic-related etiologies for changes in impedance that warrant consideration by the implanting physician.
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http://dx.doi.org/10.1007/s40122-020-00219-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119585PMC
June 2021

Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study.

J Pain Res 2020 10;13:2861-2867. Epub 2020 Nov 10.

Carolinas Pain Institute, Winston-Salem, NC 27103, USA.

Background And Objectives: A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails.

Methods: We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS.

Results: Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.

Conclusion: Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.
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http://dx.doi.org/10.2147/JPR.S281749DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667504PMC
November 2020

A Comprehensive Practice Guideline for Magnetic Resonance Imaging Compatibility in Implanted Neuromodulation Devices.

Neuromodulation 2020 Oct 18;23(7):893-911. Epub 2020 Aug 18.

The Spine and Nerve Center of The Virginias, Charleston, WV, USA.

Objectives: The evolution of neuromodulation devices in order to enter magnetic resonance imaging (MRI) scanners has been one of understanding limitations, engineering modifications, and the development of a consensus within the community in which the FDA could safely administer labeling for the devices. In the initial decades of neuromodulation, it has been contraindicated for MRI use with implanted devices. In this review, we take a comprehensive approach to address all the major products currently on the market in order to provide physicians with the ability to determine when an MRI can be performed for each type of device implant.

Materials And Methods: We have prepared a narrative review of MRI guidelines for currently marketed implanted neuromodulation devices including spinal cord stimulators, intrathecal drug delivery systems, peripheral nerve stimulators, deep brain stimulators, vagal nerve stimulators, and sacral nerve stimulators. Data sources included relevant literature identified through searches of PubMed, MEDLINE/OVID, SCOPUS, and manual searches of the bibliographies of known primary and review articles, as well as manufacturer-provided information.

Results: Guidelines and recommendations for each device and their respective guidelines for use in and around MR environments are presented.

Conclusions: This is the first comprehensive guideline with regards to various devices in the market and MRI compatibility from the American Society of Pain and Neuroscience.
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http://dx.doi.org/10.1111/ner.13233DOI Listing
October 2020

A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain.

Pain Med 2020 08;21(8):1581-1589

Neurosurgical Services and of Clinical Research, Anesthesia Pain Care Consultants, Tamarac, Florida.

Objective: To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain.

Design: Grade the evidence for DRG stimulation.

Methods: An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria.

Results: DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies.

Conclusions: Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.
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http://dx.doi.org/10.1093/pm/pnaa005DOI Listing
August 2020

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain.

Pain Med 2020 08;21(8):1590-1603

Evidence-Based Pain Management Research and Education, Cleveland Clinic, Cleveland, Ohio, USA.

Objective: To conduct a systematic literature review of peripheral nerve stimulation (PNS) for pain.

Design: Grade the evidence for PNS.

Methods: An international interdisciplinary work group conducted a literature search for PNS. Abstracts were reviewed to select studies for grading. Inclusion/exclusion criteria included prospective randomized controlled trials (RCTs) with meaningful clinical outcomes that were not part of a larger or previously reported group. Excluded studies were retrospective, had less than two months of follow-up, or existed only as abstracts. Full studies were graded by two independent reviewers using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria.

Results: Peripheral nerve stimulation was studied in 14 RCTs for a variety of painful conditions (headache, shoulder, pelvic, back, extremity, and trunk pain). Moderate to strong evidence supported the use of PNS to treat pain.

Conclusion: Peripheral nerve stimulation has moderate/strong evidence. Additional prospective trials could further refine appropriate populations and pain diagnoses.
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http://dx.doi.org/10.1093/pm/pnaa030DOI Listing
August 2020

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Thoracic Pain: A Multicenter Case Series and a Guide for Optimal Anatomic Lead Placement.

Pain Physician 2020 07;23(4):E369-E376

School of Medicine, University of Kansas Medical Center, Kansas City, KS.

Background: Surgical options for thoracic pain are limited and carry significant risk and morbidity. Spinal cord stimulation has the potential to be used for treatment of thoracic pain, as it has been useful for treating multiple types of chronic pain. Conventional tonic stimulation is limited in the treatment of thoracic pain, as it can produce paresthesia that is difficult to localize. Conversely, high-frequency spinal cord stimulation (HF-SCS) does not activate dorsal column A Beta fibers and does not produce paresthesia, and thus may be more beneficial in treating thoracic back pain not manageable with tonic stimulation.

Objectives: To evaluate (1) the efficacy of 10 kHz HF-SCS for patients with chronic thoracic pain; and (2) appropriate paresthesia-free lead placement and programming targets for 10 kHz HF-SCS for patients with chronic thoracic pain.

Study Design: Retrospective case series.

Setting: Multisite academic medical center or pain clinic.

Methods: A retrospective chart review was performed on 19 patients with thoracic back pain who underwent HF-SCS implantation. These patients had lead placement and stimulation between the T1-T6 vertebral levels. Outcome measures collected include location of device implant, stimulation settings, and pain scores at baseline, end of trial, and 1, 6, and 12 months postimplant. Follow-up phone calls collected information on if the patient reported functional improvement, improved sleep, or decreased pain medication usage. A Wilcoxon signed-rank test compared differences in mean pain scores across time points.

Results: Significantly decreased Visual Analog Scale scores were observed with 17/19 (89.5%) patients demonstrating response to therapy (> 50% reduction in pain scores). These results were sustained relative to baseline at 1, 6, and 12 months postimplant, depending on length of follow-up. Many patients also reported functional improvement (17/19), improved sleep (14/19), and reduction in use of pain medications after implantation (9/19). A total of 15/19 patients reported best relief when contacts over T1 or T2 vertebrae were used for stimulation.

Limitations: This study is limited by its retrospective design. Additionally, including documentation from multiple sites may be prone to selection and abstraction bias. Data were also not available for all patients at all time points.

Conclusions: HF-SCS may be a viable option for significant, long-lasting pain relief for thoracic back pain. There may also be evidence for anatomically based lead placement and programming for thoracic back pain. Randomized, controlled trials with extended follow-up are needed to further evaluate this therapy.

Key Words: Thoracic pain, back pain, spinal cord stimulation, high frequency, 10 kHz.
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July 2020

Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety.

Pain Manag 2020 Sep 1;10(5):331-348. Epub 2020 Jul 1.

Florida Pain Institute, Melbourne, FL 32940, USA.

Lumbar spinal stenosis is a common degenerative spine condition. In properly selected patients, minimally invasive lumbar decompression () may be an option to improve outcomes. This review provides an in-depth description of the  procedure and a comprehensive examination of safety and efficacy. Two randomized controlled trials, together with 11 other controlled clinical studies, have established the efficacy of , which is a minimally invasive procedure that does not involve implants and has demonstrated excellent efficacy and safety. With an established safety profile equivalent to epidural steroid injections, and efficacy that has been shown to be superior to such injections, can reasonably be positioned early in the treatment algorithm for these patients. Based on extensive review of the literature, robust safety and efficacy through 2 years, and in accordance with minimally invasive spine treatment guidelines, is recommended as the first intervention after failure of conservative measures for lumbar spinal stenosis patients with neurogenic claudication and ligamentum flavum hypertrophy.
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http://dx.doi.org/10.2217/pmt-2020-0037DOI Listing
September 2020

Retrospective Analysis of Real-World Outcomes of 10 kHz SCS in Patients with Upper Limb and Neck Pain.

J Pain Res 2020 15;13:1441-1448. Epub 2020 Jun 15.

Nevro Corp., Redwood City, CA, USA.

Background: Patients living with chronic upper limb and neck (ULN) pain are reliant on often ineffective therapies as they face limited options for effective long-term treatment.

Objective: Prospective clinical studies have demonstrated that high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS) is effective in treating chronic pain in multiple etiologies including ULN pain. This study aimed at validating the findings from clinical studies on ULN in a real-world cohort.

Study Design: A retrospective, observational review.

Setting: A multicenter review between April 2016 and August 2019.

Patients And Methods: Anonymized data were extracted from a real-world database of 47 consecutive patients aged ≥18 years of age with chronic upper limb and/or neck pain who were trialed and permanently implanted with 10 kHz SCS. Patient-reported pain relief, quality of life, function, sleep and medication use were extracted from anonymised patient records where available. Responder rates, defined as the proportion of patients with at least 50% pain relief at the end of trial and the last visit after implantation, were calculated.

Results: All patients reported successful response (≥50% pain relief) at the end of trial and >75% patients continued to respond to the therapy at the last follow-up period. Majority (72%) of patients reported improvement in function, about half of the patients (53%) reported improvement in sleep and one-third of the patients (36%) reported reducing their medication at last follow-up.

Conclusion: 10 kHz SCS provides durable pain relief to patients with chronic upper limb and neck pain.
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http://dx.doi.org/10.2147/JPR.S257071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304671PMC
June 2020

Emergence From the COVID-19 Pandemic and the Care of Chronic Pain: Guidance for the Interventionalist.

Anesth Analg 2020 08;131(2):387-394

Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio.

Background: The current coronavirus disease 2019 (COVID-19) pandemic led to a significant disruption in the care of pain from chronic and subacute conditions. The impact of this cessation of pain treatment may have unintended consequences of increased pain, reduced function, increased reliance on opioid medications, and potential increased morbidity, due to the systemic impact of untreated disease burden. This may include decreased mobility, reduction in overall health status, and increase of opioid use with the associated risks.

Methods: The article is the study of the American Society of Pain and Neuroscience (ASPN) COVID-19 task force to evaluate the policies set forth by federal, state, and local agencies to reduce or eliminate elective procedures for those patients with pain from spine, nerve, and joint disease. The impact of these decisions, which were needed to reduce the spread of the pandemic, led to a delay in care for many patients. We hence review an emergence plan to reinitiate this pain-related care. The goal is to outline a path to work with federal, state, and local authorities to combat the spread of the pandemic and minimize the deleterious impact of pain and suffering on our chronic pain patients.

Results: The article sets forth a strategy for the interventional pain centers to reemerge from the current pandemic and to set a course for future events.

Conclusions: The COVID-19 pandemic represents an overwhelming challenge to interventional pain physicians and their patients. In addition to urgent actions needed for disease mitigation, the ASPN recommends a staged return to pain management professionals' workflow.
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http://dx.doi.org/10.1213/ANE.0000000000005000DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7258839PMC
August 2020

A review of the bioelectronic implications of stimulation of the peripheral nervous system for chronic pain conditions.

Bioelectron Med 2020 24;6. Epub 2020 Apr 24.

Spine and Nerve Center for the Virginias, 400 Court Street, Suite 100, Charleston, West Virginia 25301 USA.

Background: Peripheral Nerve Stimulation has been used to treat human disease including pain for several decades. Innovation has made it a more viable option for treatment of common chronic pain processes, and interest in the therapy is increasing.

Main Body: While clinical data is forthcoming, understanding factors that influence successful outcomes in the use of PNS still needs to be delineated. This article reviews the evolution and bioelectronic principles of peripheral nerve stimulation including patient selection, nerve targets, techniques and guidance of target delivery. We collate the current evidence for outcomes and provide recommendations for salient topics in PNS.

Conclusion: Peripheral nerve stimulation has evolved from a surgically invasive procedure to a minimally invasive technique that can be used early in the treatment of peripheral nerve pain. This review identifies and addresses many of the variables which influence the success of PNS in the clinical setting.
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http://dx.doi.org/10.1186/s42234-020-00045-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7181529PMC
April 2020

Impact of COVID-19 on Pain Medicine Fellowship Training.

Reg Anesth Pain Med 2021 02 27;46(2):188-189. Epub 2020 Apr 27.

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.

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http://dx.doi.org/10.1136/rapm-2020-101534DOI Listing
February 2021

Pain relief and improvement in quality of life with 10 kHz SCS therapy: Summary of clinical evidence.

CNS Neurosci Ther 2020 04 22;26(4):403-415. Epub 2020 Feb 22.

Nevro Corp., Redwood City, CA, USA.

Objective: Chronic pain is a prevalent condition which has a significant effect on the lives of those it impacts. High-frequency 10 kHz spinal cord stimulation (10 kHz SCS) has been shown to provide paresthesia-free pain relief for a wide variety of pain indications. This article summarizes the current and emerging data as they relate to the clinical use of the therapy in various pain syndromes.

Methods: A literature search was conducted using the PubMed electronic database using keywords related to 10 kHz SCS. The database was queried from 2013 to May 2019. Articles reporting clinical studies that included human subjects permanently treated with 10 kHz SCS (Senza® system) were included in the review. Recent and relevant conference proceedings known to the authors were also included.

Results: The selected literature demonstrated significant evidence for the efficacy of 10 kHz SCS in treating chronic back and leg pain (CBLP), including a randomized, controlled trial as well as prospective and retrospective studies. One-year follow-up responder rates (pain relief ≥50%) ranged from 60% to 80%. Other studies and case series showed promising outcomes in specific conditions, including nonsurgical refractory back pain, neuropathic limb pain, complex regional pain syndrome, chronic widespread pain, chronic pelvic pain, and intractable headache. Subgroup analyses also pointed toward the potential of 10 kHz SCS being successful when low-frequency SCS has failed. The vast majority of these studies reported improved quality of life (QOL) metrics and/or reduced opioid consumption.

Conclusions: Level I evidence already exists for the efficacy of 10 kHz SCS in treating CBLP, supported by real-world clinical experience. Other studies demonstrate the potential of the therapy across a range of chronic pain etiologies, although larger confirmatory studies are recommended. Overall, the literature suggests that the therapy is associated with improved QOL as well as reduced opioid consumption.
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http://dx.doi.org/10.1111/cns.13285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7080433PMC
April 2020

Biomechanics and Mechanism of Action of Indirect Lumbar Decompression and the Evolution of a Stand-alone Spinous Process Spacer.

Pain Med 2019 12;20(Suppl 2):S14-S22

Milestone Research Organization, San Diego, California, USA.

Objective: Objective Interspinous process spacers are used in the treatment of lumbar spinal stenosis by preventing extension at the implanted level and reducing claudication, which is a common symptom of lumbar spinal stenosis. This review assessed the current safety and performance of lumbar spinal stenosis treatments and the biomechanical effects of spinal position, range of motion, and the use of interspinous process spacers.

Method: Method EMBASE and PubMed were searched to find studies reporting on the safety and performance of nonsurgical treatment, including physical therapy and pharmacological treatment, and surgical treatment, including direct and indirect lumbar decompression treatment. Results were supplemented with manual searches to include studies reporting on the use of interspinous process spacers and the review of biomechanical testing performed on the Superion device.

Results: Results The effects of spinal position in extension and flexion have been shown to have an impact in the variation in dimensions of the spinal canal and foramina areas. Overall studies have shown that spinal positions from flexion to extension reduce the spinal canal and foramina dimensions and increase ligamentum flavum thickness. Biomechanical test data have shown that the Superion device resists extension and reduces angular movement at the implantation level and provides significant segmental stability.

Conclusions: Conclusions Superion interspinous lumbar decompression is a minimally invasive, low-risk procedure for the treatment of lumbar spinal stenosis, which has been shown to have a low safety profile by maintaining sagittal alignment, limiting the potential for device dislodgment or migration, and to preserve mobility and structural elements.
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http://dx.doi.org/10.1093/pm/pnz129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7101165PMC
December 2019

An Algorithmic Approach to Treating Lumbar Spinal Stenosis: An Evidenced-Based Approach.

Pain Med 2019 12;20(Suppl 2):S23-S31

Milestone Research Organization, San Diego, California, USA.

Objective: Lumbar spinal stenosis (LSS) can lead to compression of the neural and vascular elements and is becoming more common due to degenerative changes that occur because of aging processes. Symptoms may manifest as pain and discomfort that radiates to the lower leg, thigh, and/or buttocks. The traditional treatment algorithm for LSS consists of conservative management (physical therapy, medication, education, exercise), often followed by epidural steroid injections (ESIs), and when nonsurgical treatment has failed, open decompression surgery with or without fusion is considered. In this review, the variables that should be considered during the management of patients with LSS are discussed, and the role of each treatment option to provide optimal care is evaluated.

Results: This review leads to the creation of an evidence-based practical algorithm to aid clinicians in the management of patients with LSS. Special emphasis is directed at minimally invasive surgery, which should be taken into consideration when conservative management and ESI have failed.
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http://dx.doi.org/10.1093/pm/pnz133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7101167PMC
December 2019

A Review of Emerging Evidence for Utilization of a Percutaneous Interspinous Process Decompression Device to Treat Symptomatic Lumbar Adjacent-Segment Degeneration.

Pain Med 2019 12;20(Suppl 2):S9-S13

Milestone Research Organization, San Diego, California.

Objective: Postlaminectomy syndrome diagnoses secondary to adjacent segment degeneration are a substantial and rising cause of morbidity in the United States. Emerging spinal cord neuromodulation technologies have produced successful outcomes for postlaminectomy neuropathic pain but are less effective in treating neurogenic claudication secondary to recurrent lumbar stenosis. Percutaneous interspinous process decompression systems can be used as a salvage treatment modality for persistent structural neurogenic claudication in postlaminectomy syndrome or after spinal cord stimulator implantation.

Methods: This paper is a review of emerging evidence for efficacious utilization of percutaneous interspinous process decompression.

Results: A recent pragmatic trial of subjects who underwent percutaneous interspinous process decompression for lumbar stenosis with intermittent neurogenic claudication reported that 63% (26/41) maintained minimal clinically important improvement in visual analog scale (VAS) leg pain, 61% (25/41) in VAS back pain, 78% (32/41) in function objective values, and 88% (36/41) reported satisfaction with treatment at 12 months postop. All subjects in a small case series of seven individuals with postlaminectomy adjacent-segment disease reported postoperative satisfaction scores of 3 or 4 on a 0-4 scale and were also able to decrease or wean completely off controlled pain medications. In another study, there was a significant decrease in average leg pain (60% improvement, P < 0.0001, N = 25) and axial low back pain (58% improvement, P < 0.0001, N = 25) in patients who underwent one- or two-level percutaneous interspinous process decompression as a rescue treatment for reemerging neurogenic claudication after spinal cord stimulator implantation.

Conclusions: The spine often is a focus of progressive disease. Furthermore, mechanical changes associated with spinal instrumentation can lead to additional disease at adjacent levels. Many individuals will present with symptomatic neurogenic claudication recalcitrant to multimodal management strategies, including even the most sophisticated neuromodulation technologies. Implementation of salvage percutaneous interspinus process decompression implantation in cases of adjacent segment degeneration or incomplete spinal cord stimulation can decompress structural causes of neurogenic claudication while sparing the patient from more invasive surgical reoperation techniques.
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http://dx.doi.org/10.1093/pm/pnz247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7182911PMC
December 2019

A Review of Lumbar Spinal Stenosis with Intermittent Neurogenic Claudication: Disease and Diagnosis.

Pain Med 2019 12;20(Suppl 2):S32-S44

Precision Spine Care, Texas Spine and Joint Hospital, Tyler, Texas, USA.

Objective: Lumbar spinal stenosis (LSS) is a degenerative spinal condition affecting nearly 50% of patients presenting with lower back pain. The goal of this review is to present and summarize the current data on how LSS presents in various populations, how it is diagnosed, and current therapeutic strategies. Properly understanding the prevalence, presentation, and treatment options for individuals suffering from LSS is critical to providing patients the best possible care.

Results: The occurrence of LSS is associated with advanced age. In elderly patients, LSS can be challenging to identify due to the wide variety of presentation subtleties and common comorbidities such as degenerative disc disease. Recent developments in imaging techniques can be useful in accurately identifying the precise location of the spinal compression. Treatment options can range from conservative to surgical, with the latter being reserved for when patients have neurological compromise or conservative measures have failed. Once warranted, there are several surgical techniques at the physician's disposal to best treat each individual case.
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http://dx.doi.org/10.1093/pm/pnz161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7101166PMC
December 2019

Cost-effectiveness and Safety of Interspinous Process Decompression (Superion).

Pain Med 2019 12;20(Suppl 2):S2-S8

MileStone Research Organization, San Diego, California, USA.

Objective: There are several treatment options for patients suffering from lumbar spinal stenosis, including surgical and conservative care. Interspinous spacer decompression using the Superion device offers a less invasive procedure for patients who fail conservative treatment before traditional decompression surgery. This review assesses the current cost-effectiveness, safety, and performance of lumbar spinal stenosis treatment modalities compared with the Superion interspinous spacer procedure.

Methods: EMBASE and PubMed were searched to find studies reporting on the cost-effectiveness, safety, and performance of conservative treatment, including medicinal treatments, epidural injections, physical therapy, and alternative methods, as well as surgical treatment, including laminectomy, laminectomy with fusion, and interspinous spacer decompression. Results were supplemented with manual searches.

Results: Despite substantial costs, persistent conservative treatment (>12 weeks) of lumbar spinal stenosis showed only minimal improvement in pain and functionality. When conservative treatment fails, surgery is more effective than continuing conservative treatment. Lumbar laminectomy with fusion has considerably greater cost than laminectomy alone, as the length of hospital stay increases, the costs for implants are substantial, and complications increase. Although laminectomy and the Superion have comparable outcomes, the Superion implant is positioned percutaneously. This approach may minimize the direct and indirect costs of outpatient rehabilitation and absenteeism, respectively.

Conclusions: Superion interspinous lumbar decompression is a minimally invasive procedure for patients with lumbar spinal stenosis who have failed conservative treatment. Compared with extending conservative treatment or traditional spinal surgery, interspinous lumbar decompression reduces the direct and indirect costs associated with lumbar spinal stenosis.
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http://dx.doi.org/10.1093/pm/pnz245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6896024PMC
December 2019

Pain medicine: if we want to be surgeons, we must have surgical training.

Reg Anesth Pain Med 2020 Jul 8;45(7):561-562. Epub 2019 Nov 8.

Department of Anesthesiology and Perioperative Medicine. Division of Pain Medicine, Mayo Clinic, Rochester, Minnesota, USA.

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http://dx.doi.org/10.1136/rapm-2019-101105DOI Listing
July 2020

Conventional versus High-Frequency Neuromodulation in the Treatment of Low Back Pain Following Spine Surgery.

PM R 2019 12;11(12):1346-1353

Department of Rehabilitation Medicine, Weill Cornell Center for Comprehensive Spine Care, Weill Cornell Medicine, New York, NY.

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http://dx.doi.org/10.1002/pmrj.12270DOI Listing
December 2019

Interspinous Process Decompression With The Superion Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry.

Med Devices (Auckl) 2019 3;12:423-427. Epub 2019 Oct 3.

Independent Clinical Consultant, San Francisco, CA 94115, USA.

Background: Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS).

Methods: IPD used the Superion Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months.

Results: The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426).

Conclusion: These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.
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http://dx.doi.org/10.2147/MDER.S220431DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6781846PMC
October 2019

Spinal Radiofrequency Ablation Combined with Cement Augmentation for Painful Spinal Vertebral Metastasis: A Single-Center Prospective Study.

Pain Physician 2019 09;22(5):E441-E449

University of Kansas Medical Center, Kansas City, KS.

Background: The spine is the most common site of skeletal metastatic disease. Vertebral body metastases (VBM) can cause crippling pain, fractures, and spinal cord compression. Radiofrequency ablation (RFA) is a minimally invasive technique that has proven to be a safe method of targeted tissue destruction. Studies have shown that RFA combined with cement vertebral augmentation is safe and effective and has been associated with significant improvements in pain and quality of life.

Objectives: The purpose of this study was continued evaluation of the safety and efficacy of this technique.

Study Design: Prospective cohort.

Setting: A single academic medical center.

Methods: Patients undergoing RFA with cement vertebral augmentation for a painful thoracic or lumbar VBM were eligible for inclusion. Additional inclusion criteria included pain concordant with a metastatic lesion on cross-sectional imaging, aged 18 years or older, and considered candidates for spinal tumor ablation by the operating physician. Patients with vertebral metastatic disease in the cervical spine or patients with spinal cord compression from posterior tumor extension were excluded. Ablation within each VBM was performed using a bipolar radiofrequency probe with an extensible electrode and available articulation, permitting vertebral body navigation percutaneously. Patients were evaluated at baseline, 3 days, one week, one month, and 3 months using the Numeric Rating Scale (NRS-11) and Functional Assessment of Cancer Therapy-General 7 (FACT-G7) to assess pain and quality-of-life, respectively. A one-sample t test was performed, and 95% confidence intervals were calculated to assess changes in average NRS-11 and FACT-G7 scores.

Results: A total of 30 patients met inclusion criteria and underwent RFA of one or more VBM. Patients with 13 different primary cancers types underwent treatment. Patients received RFA to either one (n = 26; 87%) or 2 vertebral body levels (n = 4; 13%). Of the 34 levels, 13 were thoracic vertebra (38%) and 21 were lumbar vertebra (62%). Average NRS-11 scores decreased from a baseline of 5.77 to 4.65 (3 days; P = 0.16), 3.33 (one week; P < 0.01), 2.64 (one month; P < 0.01), and 2.61 (3 months; P < 0.01). FACT-G7 increased from a baseline average of 13.0 to 14.7 (3 days; P = 0.13), 14.69 (one week; P = 0.15), 14.04 (one month; P = 0.35), and 15.11 (3 months; P = 0.07). No major adverse events were reported.

Limitations: A heterogeneous patient population, small sample size, and potential confounders of concurrent variable adjuvant therapies were limitations. Additionally, most patients received both cement augmentation and targeted RFA, making it difficult to distinguish independent analgesic benefits of the therapies.

Conclusions: This study demonstrates that minimally invasive targeted RFA with cement augmentation of spinal metastatic lesions is an effective treatment for patients with VBM.

Key Words: Cancer, cancer pain, spinal metastasis, radiofrequency ablation, tumor ablation, cement augmentation.
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September 2019

Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study.

Neuromodulation 2020 Jan 19;23(1):109-117. Epub 2019 Jul 19.

The Spine and Nerve Center of the Virginias, Charleston, WV, USA.

Objective: The purpose of this study was to compare the trial success rate between anatomic lead placement (AP) and paresthesia-mapped (PM) lead placement techniques for spinal cord stimulation (SCS) using a nonlinear burst stimulation pattern.

Materials And Methods: Eligible patients with back and/or leg pain with a Numeric Rating Scale (NRS) score of ≥6 who had not undergone previous SCS were enrolled in the study. A total of 270 patients were randomized in a 1:1 ratio to each treatment arm. In the AP group, one lead tip was placed at the mid-body of T8, and the other at the superior endplate of T9. In the PM group, physicians confirmed coverage of the patient's primary pain location. Trial success was a composite of the following: ≥50% patient-reported pain relief at the end of the minimum three-day trial period, physician's recommendation, and patient's interest in a permanent implant.

Results: Trial success for AP vs. PM groups was equivalent to 84.4% and 82.3%, respectively. Physicians who performed both techniques preferred AP technique (70% vs. 30%). Procedure times for placement of two leads were 31% shorter in the AP group (p < 0.0001). Decrease in the mean NRS pain score was similar between groups (53.2%, AP group; 53.8%, PM group, p = 0.79). Trial success for patients who went on to an extended trial with tonic stimulation was 50% (5/10) vs. 79% (11/14) for AP group and PM group, respectively (p = 0.2). A total of 13 adverse events were observed (4.5%), most commonly lead migrations and pain around implant site, with no difference between groups.

Conclusions: When using a nonlinear burst stimulation pattern, anatomic or PM lead placement technique may be used. Nonresponders to subthreshold stimulation had a higher conversion rate when a PM technique was used. AP resulted in shorter procedure times with a similar safety profile and was strongly preferred by trialing physicians.
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http://dx.doi.org/10.1111/ner.13019DOI Listing
January 2020