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1.
Reg Anesth Pain Med ; 2021 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-33688038

RESUMO

INTRODUCTION: Interventional pain procedures have increased in complexity, often requiring longer radiation exposure times and subsequently higher doses. The practicing physician requires an in-depth knowledge and evidence-based knowledge of radiation safety to limit the health risks to themselves, patients and healthcare staff. The objective of this study was to examine current radiation safety practices and knowledge among interventional pain physicians and compare them to evidence-based recommendations. MATERIALS AND METHODS: A 49-question survey was developed based on an extensive review of national and international guidelines on radiation safety. The survey was web-based and distributed through the following professional organizations: Association of Pain Program Directors, American Academy of Pain Medicine, American Society of Regional Anesthesia and Pain Medicine, European Society of Regional Anesthesia and Pain Therapy, International Neuromodulation Society, and North American Neuromodulation Society. Responses to radiation safety practices and knowledge questions were evaluated and compared with evidence-based recommendations. An exploratory data analysis examined associations with radiation safety training/education, geographical location, practice type, self-perceived understanding, and fellowship experience. RESULTS: Of 708 responding physicians, 93% reported concern over the health effects of radiation, while only 63% had ever received radiation safety training/education. Overall, ≥80% physician compliance with evidence-based radiation safety practice recommendations was demonstrated for only 2/15 survey questions. Physician knowledge of radiation safety principles was low, with 0/10 survey questions having correct response rates ≥80%. CONCLUSION: We have identified deficiencies in the implementation of evidence-based practices and knowledge gaps in radiation safety. Further education and training are warranted for both fellowship training and postgraduate medical practice. The substantial gaps identified should be addressed to better protect physicians, staff and patients from unnecessary exposure to ionizing radiation during interventional pain procedures.

2.
Pain Med ; 22(4): 807-818, 2021 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-33779730

RESUMO

OBJECTIVE: For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS. METHODS: This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established. RESULTS: 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option-Persistent spinal pain syndrome-was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification. CONCLUSIONS: This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession.

3.
Pain Ther ; 2021 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-33624253

RESUMO

INTRODUCTION: Multidisciplinary patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The use of multidisciplinary patient-reported outcomes is recommended in many areas of medicine. The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has been utilized as a common measurement language across universally relevant domains, including pain, mood, sleep, social participation, and function. METHODS: Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into chronic pain centers across 24 sites in the United States. The PROMIS-29 v2.1 and the numerical rating scale (NRS) were recorded. The pain impact score and the Health Utilities Index Mark 3 (HUI-3) were calculated. Statistical differences were assessed between genders and among age groups comprising subjects less than 40, 41-60, 61-80, and over 80 years of age. RESULTS: A total of 19,546 patients were assessed over the enrollment period from 2018 to 2020. The PROMIS-29 v2.1 was evaluated across the seven domains, along with the numerical rating sale (NRS). The mean scores of the population for PROMIS SF v1.0 Pain Interference 4a, PROMIS SF v1.0 Sleep Disturbance 4a, PROMIS SF v1.0 Fatigue 4a, PROMIS SF v1.0 Anxiety 4a, PROMIS SF V1.0 Depression 4a, PROMIS SF v2.0 Ability to Participate in Social Roles and Activities 4a, and PROMIS SF v1.0 Physical Function 4a, measuring pain interference, sleep disturbance, fatigue, anxiety, depression, social participation, and physical function, were 64.61, 57.19, 58.50, 53.94, 54.45, 40.06, and 36.23, respectively. Pain intensity was 6.38 on an 11-point NRS scale. The pain impact score (PIS) and health utilities index mark 3 (HUI-3) scores, calculated across the designated age groups, were 33.19 and 0.67, respectively. Statistical differences were observed for the domains of sleep disturbance and physical function for age groups less than 40 and greater than 80 years of age. CONCLUSION: This data set is the first published normative data set describing the PROMIS-29 assessment in the chronic pain population. The patient population is more homogeneous than expected, and females were found to have higher levels of dysfunction.

4.
Pain Med ; 22(3): 548-560, 2021 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-33616178

RESUMO

OBJECTIVE: Lumbar radiofrequency ablation is a commonly used intervention for chronic back pain. However, the pain typically returns, and though retreatment may be successful, the procedure involves destruction of the medial branch nerves, which denervates the multifidus. Repeated procedures typically have diminishing returns, which can lead to opioid use, surgery, or implantation of permanent neuromodulation systems. The objective of this report is to demonstrate the potential use of percutaneous peripheral nerve stimulation (PNS) as a minimally invasive, nondestructive, motor-sparing alternative to repeat radiofrequency ablation and more invasive surgical procedures. DESIGN: Prospective, multicenter trial. METHODS: Individuals with a return of chronic axial pain after radiofrequency ablation underwent implantation of percutaneous PNS leads targeting the medial branch nerves. Stimulation was delivered for up to 60 days, after which the leads were removed. Participants were followed up to 5 months after the start of PNS. Outcomes included pain intensity, disability, and pain interference. RESULTS: Highly clinically significant (≥50%) reductions in average pain intensity were reported by a majority of participants (67%, n = 10/15) after 2 months with PNS, and a majority experienced clinically significant improvements in functional outcomes, as measured by disability (87%, n = 13/15) and pain interference (80%, n = 12/15). Five months after PNS, 93% (n = 14/15) reported clinically meaningful improvement in one or more outcome measures, and a majority experienced clinically meaningful improvements in all three outcomes (i.e., pain intensity, disability, and pain interference). CONCLUSIONS: Percutaneous PNS has the potential to shift the pain management paradigm by providing an effective, nondestructive, motor-sparing neuromodulation treatment.

5.
Reg Anesth Pain Med ; 46(4): 293-297, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33479116

RESUMO

INTRODUCTION: Spinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient's response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials. METHODS: This study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin's concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant. RESULTS: Based on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are -30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81). CONCLUSION: Although the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

6.
Neuromodulation ; 2021 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-33508161

RESUMO

INTRODUCTION: Dorsal root ganglion (DRG) stimulation is an effective treatment option for lower extremity complex regional pain syndrome and other focal pain conditions. However, the patient characteristics that may predict long-term outcomes have not been defined. MATERIALS AND METHODS: This was a retrospective observational study that included 93 patients who were implanted with a DRG stimulator at a single private practice institution. A variety of demographic data was collected. Follow-up results were reviewed from multiple time points more than 12 months. Patients were classified as either "responder" or "nonresponder" status using two different thresholds, "greater than or equal to 50% pain relief" and "greater than or equal to 80% pain relief." RESULTS: A history of prior chronic opioid use was associated with significantly lower rates of responder status based on both a 50% pain relief threshold and 80% pain relief threshold at the one week to one month, three months, and 12-months visits. CONCLUSIONS: This single-center retrospective study found patients prescribed chronic opioids at the time of DRG stimulator implantation had a higher likelihood of less than 50% pain relief and 80% pain relief at one month, three months, and 12 months follow-up visits.

8.
Pain Med ; 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33175169
9.
Spine J ; 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33045417

RESUMO

BACKGROUND CONTEXT PURPOSE: Evaluate the safety and efficacy of a single injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36 months follow-up. STUDY DESIGN/SETTING: A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and one in Australia). SUBJECT SAMPLE: A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3-6) at one level from L1 to S1 for at least 6 months and failing three months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment. OUTCOME MEASURES: Subjects were clinically and radiographically evaluated at 1, 3, 6, 12, 24, and 36 months post-injection. Subject reported outcomes including adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index (WPAI) were collected. METHODS: Clinical and radiographic measures were collected at each visit. All randomized subjects were included in the safety assessments and analyzed based on the treatment received. Safety assessments included assessments of AEs, physical and radiographic examinations and laboratory testing. Efficacy assessments evaluated changes in VAS, ODI and modified Pfirrmann (MP) scores between all active and control groups respectively. Assessments included least squares mean (Mean), LS mean change from baseline (Mean Change) and responder analyses in order to assess the clinical significance of observed changes from baseline. The population for efficacy assessments was adjusted for the confounding effects of post-treatment interventions (PTIs). This study was conducted under an FDA Investigational New Drug (IND) application sponsored and funded by [identifying information removed for blinding purposes]. RESULTS: There were significant differences between the control and MPC groups for improvement in VAS and ODI. The PTI corrected VAS and ODI Means and Mean Change analyses; the proportion of subjects with VAS ≥30% and ≥50% improvement from baseline; absolute VAS score ≤ 20; and ODI reduction ≥10 and ≥15 points from baseline showed MPC therapy superior to controls at various timepoints through 36 months. Additionally, the proportion of subjects achieving the minimally important change (MIC) and clinically significant change (CSC) composite endpoints for the MPC groups was also superior compared with controls at various time points from baseline to 36 months. There were no significant differences in change in MP score from baseline across the groups. There were also no statistically significant differences in change in modified MP score at the level above or below the level treated between study arms. Both the procedure and treatment were well tolerated and there were no clinical symptoms of immune reaction to allogeneic MPCs. There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and the rates of these events in the MPC groups were not significantly different from the control groups. One TEAE of severe back pain was possibly related to study agent and one TEAE of implantation site infection was considered to be related to the study procedure. CONCLUSIONS: Results provide evidence that intra-discal injection of MPCs could be a safe, effective, durable and minimally invasive therapy for subjects who have CLBP associated with moderate DDD.

11.
Pain Med ; 21(8): 1590-1603, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32803220

RESUMO

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.

12.
Pain Med ; 21(8): 1581-1589, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32803221

RESUMO

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.

13.
Pain Pract ; 2020 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-32654319

RESUMO

BACKGROUND: Low back pain is the leading cause of years lost to disability worldwide. Approximately 15% to 45% of chronic low back pain is due to facet joint arthropathy. Currently, no large-scale retrospective studies have investigated long-term clinical predictors of success in individuals receiving radiofrequency ablation (RFA) of the medial branches for facet joint arthropathy. OBJECTIVE: To determine the clinical factors associated with success and failure of RFA of lumbar facet joints at 1-year follow-up. METHODS: Clinical data were gathered from 500 consecutive patients with an International Classification of Diseases (ICD)-10 diagnosis of lumbar spondylosis. VAS pain scores for patients undergoing lumbar medial branch RFA procedures were recorded at multiple time points, up to the 1-year follow-up visit. A responder was defined as having ≥30% improvement in VAS score from the pre-procedural VAS score. For our primary analysis, regression analysis was conducted to identify associations between responder status and patient characteristics, including age, gender, body mass index (BMI), hormone use, opiate dose, and smoking history at multiple time points, up to the 1-year follow-up visit. RESULTS: A total of 500 patients were included in the study. At the 1-year post-RFA follow-up visit, responder status was associated with a lower rate of prior opioid use (43.22% vs. 55.76%, odds ratio 0.60 [95% confidence interval (CI) 0.40 to 0.92], P = 0.018), lower pre-procedural opioid consumption in oral morphine equivalents (10.16 ± 16.02 vs. 14.67 ± 20.65, ß -4.50 [95% CI -8.57 to -0.44], P = 0.030), and a higher pre-VAS pain score (6.36 ± 2.17 vs. 5.85 ± 2.17, ß 0.50 [95% CI 0.06 to 0.95], P = 0.028). There were no significant associations between responder status and age, gender, BMI, hormone use, and smoking history at the 1-year follow-up visit. CONCLUSIONS: Our results suggest that patients prescribed opioids, particularly at higher dosages, may find less pain relief 1 year following RFA for facetogenic pain. Additionally, patients with higher pre-procedural VAS pain scores may be more likely to have a positive response at 1 year.

14.
Med Devices (Auckl) ; 13: 151-161, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32581602

RESUMO

Background and Purpose: Minimally invasive lumbar decompression (mild ®) is an effective long-term therapy for patients with symptomatic lumbar spinal stenosis (LSS) resulting primarily from hypertrophic ligamentum flavum (HLF). Most subjects in clinical studies of the mild procedure have been older adults (age≥65). While the incidence of LSS increases with age, a substantial number of adults (age<65) also suffer from neurogenic claudication secondary to HLF. In this report, outcomes of mild were compared between adults and older adults. Patients and Methods: All prospective studies of the mild procedure with a 1-year follow-up completed since the beginning of 2012 that allowed the inclusion of adult patients of all ages were reviewed. Outcomes of visual analog scale (VAS), Oswestry Disability Index (ODI), Pain Disability Index (PDI), Roland Morris Low Back Pain and Disability Questionnaire (RMQ), standing time and walking distance were compared for adults and older adults. Results: Four studies met the inclusion criteria, resulting in an analysis of 49 adults and 160 older adults. Patients in both age groups experienced significant mean improvements in all but one outcome measure at 6- and 12-month follow-up. Differences between the two age groups in all scores at 6 and 12 months were not statistically significant. Conclusion: Analysis of the four studies indicated that symptom improvements for adults and older adults were significant from baseline, and no statistically significant difference was observed between the two age groups. These results illustrate that mild can be an effective treatment for LSS due primarily to HLF, regardless of the adult patient age.

16.
Pain Ther ; 9(2): 511-529, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32495188

RESUMO

INTRODUCTION: Chronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to painful symptoms. METHODS: We describe the clinical validation of a multi-biomarker assay with algorithmic analysis known as the Foundation Pain Index (FPI) in diverse cohorts of chronic pain patients in a prospective, cross-sectional, observational validation study. Levels of 11 urinary pain biomarkers were measured and tabulated using a proprietary algorithm to generate FPI scores for chronic pain subjects (N = 153) and age- and sex-matched pain-free controls (N = 334). RESULTS: FPI scores were significantly correlated with the 36-Item Short Form Health Survey (SF-36) scores among chronic pain subjects (P value < 0.015) and specific components of SF-36, including emotional well-being, limitations due to emotional problems, and general health (P value < 0.05). Area under ROC analysis (AUROC) revealed FPI to accurately distinguish biomarker profiles between pain-free and chronic pain cohorts (AUROC: 0.7490, P value < 0.0001) as well as the SF-36 scores between chronic pain subjects with low vs. high FPI scores (AUROC: 0.7715, P value < 0.01). CONCLUSIONS: Our findings establish the validity and discriminatory power of a novel multi-biomarker test that evaluates the role of biochemistry in chronic pain and correlates with clinical assessments of patients. This test provides novel, reproducible, objective data which may pave the way for non-opioid therapeutic strategies to treat chronic pain.

17.
Pain Manag ; 10(4): 225-233, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32423306

RESUMO

Chronic pain is consistently listed as one of the most costly and disabling health problems worldwide. In an effort to treat these suffering individuals, significant amounts of time and energy have been devoted to discover safe and effective pain relieving treatments. Dorsal root ganglion stimulation is the newest treatment modality to be created for chronic intractable pain. In this manuscript, we review the history and development, published research and safety profile of the Proclaim™ DRG Neurostimulator System (Abbott, TX, USA). At last, we offer our outlook on future developments with dorsal root ganglion stimulation.

18.
Anesth Analg ; 131(2): 387-394, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32452905

RESUMO

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.


Assuntos
Betacoronavirus/patogenicidade , Dor Crônica/terapia , Infecções por Coronavirus/terapia , Procedimentos Clínicos , Manejo da Dor , Pneumonia Viral/terapia , Dor Crônica/diagnóstico , Dor Crônica/epidemiologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Nível de Saúde , Humanos , Manejo da Dor/efeitos adversos , Pandemias , Segurança do Paciente , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Medição de Risco , Fatores de Risco , Resultado do Tratamento
19.
Bioelectron Med ; 6: 9, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32346553

RESUMO

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.

20.
Neuromodulation ; 2020 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-32153073

RESUMO

OBJECTIVES: ACCURATE, a randomized controlled trial, compared safety and effectiveness of stimulation of the dorsal root ganglion (DRG) vs. conventional spinal cord stimulation (SCS) in complex regional pain syndrome (CRPS-I and II) of the lower extremities. This analysis compares cost-effectiveness of three modalities of treatment for CRPS, namely DRG stimulation, SCS, and comprehensive medical management (CMM). MATERIALS AND METHODS: The retrospective cost-utility analysis combined ACCURATE study data with claims data to compare cost-effectiveness between DRG stimulation, SCS, and CMM. Cost-effectiveness was evaluated using a Markov cohort model with ten-year time horizon from the U.S. payer perspective. Incremental cost-effectiveness ratio (ICER) was reported as cost in 2017 U.S. dollars per gain in quality-adjusted life years (QALYs). Willingness-to-pay thresholds of $50,000/QALY and $100,000/QALY were used to define highly cost-effective and cost-effective therapies. RESULTS: Both DRG and SCS provided an increase in QALYs (4.96 ± 1.54 and 4.58 ± 1.35 QALYs, respectively) and an increase in costs ($153,992 ± $36,651 and $128,269 ± $27,771, respectively) compared to CMM (3.58 ± 0.91 QALYs, $106,173 ± $27,005) over the ten-year model lifetime. Both DRG stimulation ($34,695 per QALY) and SCS ($22,084 per QALY) were cost-effective compared to CMM. In the base case, ICER for DRG v SCS was $68,095/QALY. CONCLUSIONS: DRG and SCS are cost-effective treatments for chronic pain secondary to CRPS-I and II compared to CMM. DRG accrued higher cost due to higher conversion from trial to permanent implant and shorter battery life, but DRG was the most beneficial therapy due to more patients receiving permanent implants and experiencing higher quality of life compared to SCS. New DRG technology has improved battery life, which we expect to make DRG more cost-effective compared to both CMM and SCS in the future.

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