Interventional Spine and Pain Procedure Credentialing: Guidelines from the American Society of Pain & Neuroscience

Background: The discipline of interventional pain management has changed significantly over the past decade with an expected greater evolution in the next decade. Not only have the number of procedures increased, some of the procedures that were created for spine surgeons are becoming more facile in the hands of the interventional pain physician. Such change has outpaced academic institutions, societies, and boards. When a pain physician is in the credentialing process for novel procedure privileges, it can leave the healthcare system in a challenging situation with little to base their decision upon. Methods: This paper was developed by a consensus working group from the American Society of Pain and Neuroscience from various disciplines. The goal was to develop processes and resources to aid in the credentialing process. Results: These guidelines from the American Society of Pain and Neuroscience provide background information to help facilities create a process to appropriately credential physicians on novel procedures. They are not intended to serve as a standard or legal precedent. Conclusion: This paper serves as a guide for facilities to credential physicians on novel procedures

Durability of high-frequency 10-kHz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments: 12-month results from a randomized controlled trial

No abstract available

A randomized controlled trial of high frequency (10 kHz) spinal cord stimulation in painful diabetic neuropathy

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: NCT0322842

Posterior intra-articular fixation stabilizes both primary and secondary sacroiliac joints: a cadaveric study and comparison to lateral trans-articular fixation literature

Abstract Background Posterior and lateral techniques have been described as approaches to sacroiliac joint arthrodesis. The purpose of this study was to compare the stabilizing effects of a novel posterior stabilization implant and technique to a previously published lateral approach in a cadaveric multidirectional bending model. We hypothesized that both approaches would have an equivalent stabilizing effect in flexion–extension and that the posterior approach would exhibit better performance in lateral bending and axial rotation. We further hypothesized that unilateral and bilateral posterior fixation would stabilize both the primary and secondary joints. Methods Ranges of motion (RoMs) of six cadaveric sacroiliac joints were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 N-m applied moment in flexion–extension, lateral bending, and axial rotation under intact, unilateral fixation, and bilateral fixation conditions. Results Intact RoMs were equivalent between both samples. For the posterior intra-articular technique, unilateral fixation reduced the RoMs of both primary and secondary joints in all loading planes (flexion–extension RoM by 45%, lateral bending RoM by 47%, and axial RoM by 33%), and bilateral fixation maintained this stabilizing effect in both joints (flexion–extension at 48%, lateral bending at 53%, and axial rotation at 42%). For the lateral trans-articular technique, only bilateral fixation reduced mean RoM of both primary and secondary sacroiliac joints, and only under flexion–extension loads (60%). Conclusion During flexion–extension, the posterior approach is equivalent to the lateral approach, while producing superior stabilization during lateral bend and axial rotation

High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study.

PurposeThis study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).MethodsA pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann-Whitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.ResultsThe average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen's d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).ConclusionA larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients

High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study.

PurposeThis study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).MethodsA pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann-Whitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.ResultsThe average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen's d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).ConclusionA larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients

A proposed definition of remission from chronic pain, based on retrospective evaluation of 24-month outcomes with spinal cord stimulation.

OBJECTIVE: In the treatment of chronic diseases, remission is commonly used as a meaningful treatment goal, synonymous with the absence of significant clinical signs and symptoms of a disease, but not representing a cure. The objective of this paper is to propose a definition for remission for use as an outcome to evaluate the long-term efficacy of therapies for chronic pain. METHODS: Data from a randomized clinical trial (NCT01609972) testing the efficacy of spinal cord stimulation in low back and leg pain subjects was used to evaluate the association between pain and functional outcomes and identify the cut-off value to predict remission. Available data over 24-month assessment period included visual analog score (VAS), disability (Oswestry Disability Index [ODI]), patient and clinician global impression of change (PGIC and CGIC), and patient satisfaction. Cluster analysis, Pearson\u27s correlation coefficients, sensitivity, and specificity analyses were used to evaluate its utility in predicting higher patient functionality and satisfaction. RESULTS: Though the term remission has been used in the chronic pain field, a consistent definition has not been previously established. Based on the analysis of the clinical data, we propose that a sustained (≥6 months) pain score of ≤3.0 cm out of 10 cm on VAS be defined as remission. Applying this definition to the clinical trial data: subjects in remission at 24 months versus non-remitters were significantly more likely to be in the highest functional category of minimally disabled according to the ODI (31.5 vs. 8.2%, respectively, p = 0.001), and be \u27very satisfied\u27 (75.7 vs 22.6%, respectively, p \u3c 0.001). CONCLUSIONS: The validity of the proposed definition of remission is supported by the persistence of remission in this study group, and its correspondence with patient satisfaction, and reduced disability. Further evaluation of the definition using clinical data from other long-term studies is needed

Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol.

BACKGROUND: Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping. METHODS: This study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation. DISCUSSION: Associations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patients pain phenotype, unique neurophysiology, and disease severity