Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-Pain® nationwide screening and follow-up interactive register.

Introduction: Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. Methods: In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Results: Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Discussion: Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process.

Five-Year Longitudinal Follow-up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Morphologic and Morphometric Measurements of the Foramen Ovale: Comparing Digitized Measurements Performed on Dried Human Crania With Computed Tomographic Imaging. An Observational Anatomic Study.

The foramen ovale (FO) of the sphenoid bone is clinically important for the interventional treatment of trigeminal neuralgia. Percutaneous procedures applied to treat the chronic pain condition typically involve the cannulation of this oval-like foramen located at the base of the skull. Anatomic variations of the FO have been reported to contribute to difficulties in the cannulation of this structure. Computed tomography (CT) can help the surgeon improve the accuracy and safety of the intervention. However, even with navigation technology, unsuccessful cannulation of the FO has been reported. The aim of this observational anatomic study was to define morphometric and morphologic data of the FO and to investigate for potential differences between measurements taken on dried human crania and digitized measurements of the FO measured on CT images. One hundred eighteen FOs were evaluated. Twenty FOs underwent CT scanning. The mean length of the foramen was 7.41±1.3 mm on the left side and 7.57±1.07 mm on the right. The mean width of the foramen was 4.63±0.86 mm on the left side and 4.33±0.99 on the right. The mean area on the left side was 27.11±7.58 and 25.73±6.64 mm 2 on the right. No significant left-right differences were found for any of these dimensions. The most important conclusion that we can draw is that the measurements can indeed be performed on CT images to obtain an accurate picture of the morphology. Considering the surgical importance of the FO and taking into consideration the limitations this study added to scientific knowledge, this study was constructive as far as neurosurgeons and anatomists are concerned.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

Complex regional pain syndrome of the knee after conventional radiofrequency ablation of the genicular nerves treated successfully with dorsal root ganglion stimulation: A case report.

BACKGROUND: Radiofrequency (RF) treatment of the genicular nerves offers pain relief in patients suffering from chronic knee pain including persistent post-surgical knee pain (PPSP). We present the first case report of the development of complex regional pain syndrome (CRPS) in a chronic knee pain patient after an RF ablation of the genicular nerves that was successfully treated with dorsal root ganglion (DRG) stimulation. CASE PRESENTATION: The patient developed increased pain, sympathetic and dysmorphic changes of the index knee 10 weeks after RF treatment for PPSP. Diagnosis of CRPS type II was made using positive clinical findings and the Budapest diagnostic tool. Laboratory workup and PET-CT were negative. The patient was refractory to usual care and she was treated successfully with dorsal ganglion root stimulation. CONCLUSIONS: Complex regional pain syndrome is a possible complication of RF ablation of the genicular nerves in patients with chronic knee pain, and DRG stimulation may be a treatment option. Physicians should be aware of this complication, especially when patients have a medical history of CRPS.

Detoxification of Neuromodulation-Eligible Patients by a Standardized Protocol: A Retrospective Pilot Study.

OBJECTIVES: Patients eligible for spinal cord stimulation (SCS) generally experience excruciating pain, requiring more opioid consumption, which is usually an indication for SCS implantation. After final implantation, SCS has the ability to stabilize or decrease opioid usage in half of the patients. In this study, opioids were actively eliminated prior to implantation of any neuromodulation device with a standardized detoxification protocol. This pilot study aims to explore the feasibility, effectiveness, and safety of this opioid detoxification protocol prior to neuromodulation techniques. MATERIALS AND METHODS: In this retrospective pilot study, 70 patients who were taking opioids and who were eligible for neuromodulation techniques underwent the detoxification program. A combined in- and out-patient clinic protocol was applied, whereby clonidine was the main component of both parts of the program. A multidisciplinary team with pain physicians and psychologists was responsible for performing this detoxification program. Safety and feasibility were systematically recorded during the hospitalization. RESULTS: No serious safety issues were reported. At the start of the program, patients reported a mild sedative effect of clonidine. Additionally, most patients presented mild symptoms of opioid withdrawal, which were partially countered by the sedative effect of clonidine. Both patients and the medical staff found this protocol feasible in clinical practice. Concerning the effectiveness, a statistically significant decrease in median morphine milligram equivalents (MMEs) was found with an MME of 175 (Q1-Q3: 118.1-240) at baseline, and at the last available follow-up visit the MME was 0 (Q1-Q3: 0-16.88). CONCLUSIONS: This standardized detoxification program has proven its effectiveness, safety, and feasibility in this single-center experience pilot study in patients eligible for neuromodulation techniques.

Dorsal root ganglion stimulation for patients with refractory pain due to anterior cutaneous nerve entrapment syndrome: A case series.

BACKGROUND: Anterior cutaneous nerve entrapment syndrome (ACNES) is a painful condition that can be refractory in a small percentage of patients. Abdominal pain caused by thoracic nerve entrapment in the abdominal wall characterizes ACNES. In the small number of refractory patients to all standard treatments, medication overuse and abuse are serious problems. Dorsal root ganglion (DRG) stimulation might be a good treatment to improve pain scores and to lower medication use. METHODS: We describe the retrospective analysis of nine cases of patients who underwent DRG stimulation for refractory ACNES using a treatment algorithm. We focused on reported pain intensity scores, medication use, and adverse events. RESULTS: All nine patients experienced a decrease in pain intensity during the trial period and received a permanent pulse generator implantation. Three months after permanent implantation, eight of nine patients showed a pain reduction of more than 50%. Medication use was substantially lower. DISCUSSION AND CONCLUSION: This case series shows that DRG stimulation might be a very good treatment for refractory ACNES.

Trigeminal neuropathy: Two case reports of gasserian ganglion stimulation.

This report describes the successful treatment of two patients with trigeminal neuropathy by using gasserian ganglion stimulation. Case reports: The first case report deals with a 53-year-old woman suffering from right-sided facial pain after a gamma knife lesion for schwannoma of the right inner ear. For 9 years, several interventions with the aim of relieving the pain were unsuccessful; in fact, they had aggravated the symptoms. A trial with a neurostimulator at the level of the Gasser ganglion had an immediately positive effect on her score for facial pain, which decreased from 7.3 to 0 on a visual analog scale, assessed during a period of 2 months. Additionally, the patient had weaned off all her medication by the end of the period. The second case report describes a 64-year-old man suffering from trigeminal neuropathy, which mainly manifested itself as an itch. For a period of 15 years, neither medication nor several interventions were effective. A trial with an electrode at the level of the Gasser ganglion reduced his pain score from 7.0 to 1.5 on a visual analog scale, assessed during a period of three months. His medication could be limited to pregabalin 150 mg bidaily. In contrast, prior to the implantation, his oral medication consisted of pregabalin 75 mg up to five times a day. Conclusion: These case reports show that stimulation of the gasserian ganglion is a successful, minimally invasive, and non-destructive treatment in refractory trigeminal neuropathy and should be considered earlier in the treatment algorithm of trigeminal neuropathy.

An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.

ABSTRACT: Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.

Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain.

OBJECTIVES: The purpose of the ongoing follow-up of ReActiv8-A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four-year outcomes of this trial. MATERIALS AND METHODS: ReActiv8-A is a prospective, single-arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30-min stimulation-sessions twice daily. Annual follow-up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ-5D). Background on mechanisms, trial design, and one-year outcomes were previously described. RESULTS: At baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ-5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. Patients completing year 4 follow-up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ-5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment. CONCLUSIONS: In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality-of-life are clinically meaningful and durable through four years.

Real-World Analysis: Long-Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome.

INTRODUCTION: Spinal cord stimulation (SCS) is effective for patients with failed back surgery syndrome (FBSS). SCS improves their pain, as well as their functionality and health-related quality of life. Different waveforms for SCS have emerged that show improvement in small prospective studies. Analysis of real-world data shows the clinical implementation and the effect of different waveforms in SCS. METHODS: A real-world analysis was performed of 208 patients with FBSS who were treated over 3 years. Stimulators with tonic, burst, high-density, and 10-kHz high-frequency (HF10) waveforms were implanted in patients with FBSS who had predominant pain in the back, legs, or both back and legs. Pain as measured by the VAS, functional disability as measured by the Oswestry Disability Index (ODI), and health-related quality of life as measured by the 3-level EuroQol 5-Dimension (EQ5D-3L) questionnaire were determined at baseline and for outcome assessment. RESULTS: SCS is effective for patients with FBSS. This analysis showed a change in baseline VAS score from 8.0 to 4.7 (P < 0.0001) at 24 months. The EQ5D-3L score improved from 0.29 to 0.49 (P < 0.0001) at 24 months. The ODI score improved from 54% to 42% (P < 0.0001) at 24 months. The unanticipated explantation rate was only 1.6%. CONCLUSION: This study of SCS showed significant long-term improvement in pain, disability, and quality of life in a large dataset of patients with FBSS. Strict selection procedures and a strong opioid policy contributed to the high success rate and low unanticipated explantation rate. There was no difference in pain reduction between tonic and HF10 stimulation. Further investigation is necessary to detect any difference between other waveforms of SCS.

Predicting the Response of High Frequency Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: A Retrospective Study with Machine Learning Techniques.

Despite the proven clinical value of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS), factors related to a successful SCS outcome are not yet clearly understood. This study aimed to predict responders for high frequency SCS at 10 kHz (HF-10). Data before implantation and the last available data was extracted for 119 FBSS patients treated with HF-10 SCS. Correlations, logistic regression, linear discriminant analysis, classification and regression trees, random forest, bagging, and boosting were applied. Based on feature selection, trial pain relief, predominant pain location, and the number of previous surgeries were relevant factors for predicting pain relief. To predict responders with 50% pain relief, 58.33% accuracy was obtained with boosting, random forest and bagging. For predicting responders with 30% pain relief, 70.83% accuracy was obtained using logistic regression, linear discriminant analysis, boosting, and classification trees. For predicting pain medication decrease, accuracies above 80% were obtained using logistic regression and linear discriminant analysis. Several machine learning techniques were able to predict responders to HF-10 SCS with an acceptable accuracy. However, none of the techniques revealed a high accuracy. The inconsistent results regarding predictive factors in literature, combined with acceptable accuracy of the currently obtained models, might suggest that routinely collected baseline parameters from clinical practice are not sufficient to consistently predict the SCS response with a high accuracy in the long-term.

Opioid-sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence.

Chronic pain is a common condition that affects the physical, emotional, and mental well-being of patients and can significantly diminish their quality of life. Due to growing concerns about the substantial risks of long-term opioid use, both governmental agencies and professional societies have recommended prioritizing the use of nonpharmacologic treatments, when suitable, in order to reduce or eliminate the need for opioid use. The use of 10 kHz spinal cord stimulation (10 kHz SCS) is one such nonpharmacologic alternative for the treatment of chronic, intractable pain of the trunk and limbs. This review examines published clinical data regarding the efficacy of 10 kHz SCS for decreasing chronic pain in patients and its potential to reduce or eliminate opioid usage. Multiple prospective and retrospective studies in patients with intractable pain demonstrated that 10 kHz SCS treatment provided ≥50% pain relief in >70% patients after at least 1 year of treatment. Pain relief with 10 kHz SCS therapy ranged from 54% to 87% in the studies. More importantly, the mean daily dose of opioids required by patients in these studies was reduced after 10 kHz SCS treatment, and on average over 60% patients in studies either reduced or eliminated opioids at the last follow-up.

10 kHz SCS therapy for chronic pain, effects on opioid usage: Post hoc analysis of data from two prospective studies.

Chronic pain, including chronic low back and leg pain are prominent causes of disability worldwide. While patient management aims to reduce pain and improve daily function, prescription of opioids remains widespread despite significant adverse effects. This study pooled data from two large prospective trials on 10 kHz spinal cord stimulation (10 kHz SCS) in subjects with chronic low back pain and/or leg pain and performed post hoc analysis on changes in opioid dosage 12 months post 10 kHz SCS treatment. Patient-reported back and leg pain using the visual analog scale (VAS) and opioid dose (milligrams morphine equivalent/day, MME/day) were compared at 12 months post-10 kHz SCS therapy to baseline. Results showed that in the combined dataset, 39.3% of subjects were taking >90 MME dose of opioids at baseline compared to 23.0% at 12 months post-10 kHz SCS therapy (p = 0.007). The average dose of opioids in >90 MME group was significantly reduced by 46% following 10 kHz SCS therapy (p < 0.001), which was paralleled by significant pain relief (P < 0.001). In conclusion, current analysis demonstrates the benefits of 10 kHz SCS therapy and offers an evidence-based, non-pharmaceutical alternative to opioid therapy and/or an adjunctive therapy to facilitate opioid dose reduction whilst delivering significant pain relief. Healthcare providers involved in management of chronic non-cancer pain can include reduction or elimination of opioid use as part of treatment plan when contemplating 10 kHz SCS.

Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Proposal of a Standardized Multidisciplinary Team Care Pathway.

Failed back surgery syndrome (FBSS) is a major, worldwide health problem that generates considerable expense for healthcare systems. A number of controversial issues concerning the management of FBSS are regularly debated, but no clear consensus has been reached. This pitfall is the result of lack of a standardized care pathway due to insufficient characterization of underlying pathophysiological mechanisms, which are essential to identify in order to offer appropriate treatment, and the paucity of evidence of treatment outcomes. In an attempt to address the challenges and barriers in the clinical management of FBSS, an international panel of physicians with a special interest in FBSS established the Chronic Back and Leg Pain (CBLP) Network with the primary intention to provide recommendations through consensus on how to optimize outcomes. In the first of a series of two papers, a definition of FBSS was delineated with specification of criteria for patient assessment and identification of appropriate evaluation tools in order to choose the right treatment options. In this second paper, we present a proposal of a standardized care pathway aiming to guide clinicians in their decision-making on how to optimize their management of FBSS patients. The utilization of a multidisciplinary approach is emphasized to ensure that care is provided in a uniform manner to reduce variation in practice and improve patient outcomes.

Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Consensus Statement on Definition and Outlines for Patient Assessment.

Failed back surgery syndrome (FBSS) is a controversial term for identifying patients affected by new, recurrent, or persistent pain in the low back and/or legs following spinal surgery. The lack of a comprehensive standardized care pathway compromises the appropriate management of FBSS patients, which is associated with a heavy financial burden. An international panel of spine surgeons, neurosurgeons, and pain specialists with a particular interest in FBSS established the chronic back and leg pain (CBLP) network with the aim of addressing the challenges and barriers in the clinical management of FBSS patients by building a common transdisciplinary vision. Based on literature reviews, additional input from clinical expertise of multiple professional disciplines, and consensus among its members, the network attempted to provide recommendations on the management of patients with FBSS utilizing a multidisciplinary team (MDT) approach. The presentation of this work has been divided in two separate parts to enhance its clarity. This first paper, in favour of selecting appropriate validated tools to improve the FBSS patient assessment, focuses on FBSS taxonomy and its clinical implications for evaluation. Concise recommendations for assessment, treatment, and outcome evaluation using a MDT approach would be an important resource for specialists and nonspecialist clinicians who manage patients with FBSS, to improve decision-making, reduce variation in practice, and optimize treatment outcomes in this difficult-to-treat population.

High-Frequency Supraorbital Nerve Stimulation With a Novel Wireless Minimally Invasive Device for Post-Traumatic Neuralgia: A Case Report.

BACKGROUND: Post-traumatic neuropathic pain in the head and face is a condition that is often refractory to medical management. Peripheral nerve stimulation (PNS) can be an effective treatment. Successful implantation of a novel minimally invasive wireless device is reported here. OBJECTIVE: To assess analgesic effects of a minimally invasive wireless PNS device in the treatment of post-traumatic supraorbital neuralgia (SON). CASE SUMMARY: The patient presented with SON following multiple post-traumatic cranioplasty surgeries, which were complicated by infections. Medical and interventional management failed, and the patient reported a numeric rating scale (NRS) pain score of 8 out of 10. Two octopolar implantable neural stimulators (INSs) (StimRelieve LLC, Pompano Beach, FL, U.S.A.) were implanted with a minimally invasive, percutaneous technique to stimulate the supraorbital nerves. Stimulation parameters were set at a frequency of 10 kHz and a pulse width of 30 microseconds. RESULTS: At 12- and 24-month follow-up evaluations, the patient's NRS score was only 2 out of 10, and the patient occasionally required 1 g of paracetamol to control the pain. Stimulation was reported to be paresthesia free. There were no adverse events related to the procedure or the treatment until today. CONCLUSIONS: High-frequency stimulation with an external pulse generator and minimally invasive, percutaneous, and bilateral placement of 2 passive INSs on the supraorbital nerves resulted in a significant pain relief in this patient with post-traumatic SON. The device was safe and effective, and the cosmesis was satisfactory.

Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements?

OBJECTIVES: To understand the subjective pain experience of patients, healthcare providers rely heavily on self-reporting. However, to quantify this unique pain experience, objective parameters are not yet available in daily clinical practice. With regard to patients with failed back surgery syndrome (FBSS) treated with spinal cord stimulation (SCS), pain therapists may recover the individual functional information about the patient's posture from the implantable pulse generator (IPG) of the stimulator. The aim of this study is to investigate whether subjective self-reporting is in correlation with the functional capacities of a patient. MATERIALS AND METHODS: Thirty-nine patients with FBSS, treated with SCS were included. The accelerometer in the IPG detects positional changes and provides an objective output of seven functional positions (lying back, lying prone, lying left, lying right, transition, upright, and upright + mobile). The Oswestry Disability Index (ODI), VAS-diary, and the Pittsburgh Sleep Quality Index (PSQI) were assessed to evaluate physical functioning, pain intensities, and subjective sleep quality. Additionally, 21 patients wore a wearable actigraph device to objectify sleep quality. The agreement and Spearman correlations between objective and subjective parameters were assessed. RESULTS: Spearman rank correlations revealed no significant correlations between the ODI (subscales walking, sitting, standing, and sleeping) and the output of the IPG (percentage upright + mobile, transition, upright, and lying, respectively). Sleep parameters measured with the Actiwatch and the PSQI were not in agreement. CONCLUSIONS: This study demonstrated that self-reporting questionnaires do not correlate with the findings of objective measurements. Therefore, we recommend using both subjective and objective parameters when determining treatment options for FBSS patients.