Association Between Pain Scores and Successful Spinal Cord Stimulator Implantation (original) (raw)
Related papers
Pain Medicine, 2011
Background. In addition to its conventional use as a treatment for refractory neuropathic extremity pain, spinal cord stimulation (SCS) has recently emerged as a possible treatment for visceral and arthritic pain. But concurrent with the expansion of possible conditions amenable to SCS, other studies have questioned the long-term efficacy of SCS for traditional indications. These disparate findings argue strongly for the refinement of selection criteria. The purpose of this study is to identify correlates of outcome for SCS.
Neuromodulation: Technology at the Neural Interface, 2008
Objectives. In spinal cord stimulation (SCS) therapy, limited pain relief during the temporary trial period is generally considered to be predictive of poor long-term benefit. To validate or refute this perception, the long-term outcomes of subjects who reported less than 50% pain relief during a temporary SCS trial were examined. Materials and Methods. Twelve subjects with intractable pain underwent implantation of trial SCS systems. After a trial period in which they reported less than 50% pain relief, they each received a permanent SCS implant. Pain ratings and complications were tracked for 6-18 months. Results. At the end of the temporary trial period, the average pain relief was 21%; no subject reported 50% or better pain relief. More favorable outcomes were reported after activation of the permanent system, however. At all follow-up time points, at least a third of the subjects reported better than 50% pain relief, and the average pain relief varied over time between 44% and 83%. All complications were readily resolved and no subjects withdrew from the study. Conclusions. Although SCS provided limited pain relief during the trial period, efficacy was more satisfactory after permanent implantation. Several subjects went on to experience nearly complete pain relief for up to 18 months (the maximum follow-up visit for study purposes), and no subject chose to discontinue SCS therapy. SCS appears to be a viable treatment option for patients who fail trials, raising some doubt as to the predictive sensitivity and specificity of the trial period. Thus, although outcome of a temporary trial period may be suggestive of later efficacy with SCS, it may not be the sole predictor of success. Alternatively, the arbitrary benchmark of 50% pain relief that is typically used to define the success of a temporary trial may be too stringent and unreliable.
2022
Introduction:Spinal cord stimulation (SCS), an FDA-approved therapy for chronic pain, uses paresthesia (low frequency SCS (LF-SCS)) or paresthesia-free (high frequency SCS (HF-SCS)) systems, providing analgesia through partially-elucidated mechanisms, with recent studies indicating a sexual dimorphism in pain pathogenesis. We aim to evaluate SCS therapy sex effects based on paradigm, utilizing visual analog scores (VAS), perceived pain reduction (PPR), and opioid use.Methods:A retrospective cohort study of SCS patients implanted between 2004-2020 (n=237) was conducted. Descriptive statistics and linear mixed methods analyses were used. Results: HF-SCS was implanted in 94 patients (40 females, 54 males), and LF-SCS in 143 (70 females, 73 males). At 3 months and 6 months, HF-SCS (p<0.001) and LF-SCS (p<0.005) had lower VAS scores compared to baseline (p<0.005), with no differences across groups. PPR improved in both post-implantation (p<0.006) and at 3 months (p<0.004 r...
Pain Management
Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 ( ClinicalTrials.gov )
Neuromodulation: Technology at the Neural Interface, 2018
Objectives: Previous studies demonstrated significant improvement in mean pain scores and quality of life (QOL) scales in patients with chronic pain who underwent spinal cord stimulation (SCS). However, the number of individuals who experience relevant improvements in QOL, termed the meaningful clinical improvement (MCI), is not known. The present study investigated changes in pain measurements based on MCI after SCS. Materials and Methods: Thirty-four patients with chronic intractable pain completed scales of pain (visual analogue scale [VAS]), QOL (SF-36), and psychological dimensions during a 22-month follow-up period (mean). Patient-centered MCI of the VAS and SF-36 domain scores were determined based on the MacNab criteria of surgical global effectiveness. Independent presurgical predictors for MCI in the VAS and SF-36 domains were analyzed using multiple binary logistic regression. Results: There was significant improvement of pain and QOL after the SCS (p < 0.00001). Twenty-three patients (67.6%) reached an MCI of pain, and 16 (47.7%)-23 (67.7%) reported an MCI of QOL. Predictors of MCI included ≥80% paresthesia coverage of the painful area, lower levels of anxiety and catastrophizing symptoms, shorter pain duration, female gender and no use of opioids before surgery. MCI of pain and QOL was observed in 50%-70% of patients with chronic pain after SCS. Conclusions: The identification of determinants for MCI is a challenge to improve the accuracy of prognostic models in SCS for patients with chronic pain. Our results, if confirmed in other populations with a larger sample size, have implications for patients with chronic pain who are candidates for SCS treatment.
Prospective Analysis of the Trial Period for Spinal Cord Stimulation Treatment for Chronic Pain
Neuromodulation: Technology at the Neural Interface, 2011
To determine patient preferences regarding the duration of trial period. Forty patients were given a trial of spinal cord stimulation. They were questioned daily if they would like to proceed to a permanent implant. Three consecutive affirmative answers implied a successful trial; three negative replies implied a failed trial. Patients rated daily the pain from the surgery, original pain, satisfaction with the stimulator, and the duration of the use of the stimulator. The trial duration varied from 3 to 15 days. Patients with a failed trial took longer to make a decision and also experienced prolonged surgical pain. The majority of patients with a successful trial experienced more than 50% pain reduction. The rate of infection was 7.5%, which has reduced to 2.8% after changing the dressing protocol. In this study, all patients could make a decision in 15 days, with successful trials requiring a shorter duration. The conversion rate was similar to rates in literature despite patients making a decision without physician input.
Trials
Background: The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and costeffectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. Methods/design: The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index) , patient satisfaction (Patients' Global Impression of Change) and complication rates. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. The economic evaluation will take the form of a cost-utility analysis. Discussion: The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The nested qualitative study will seek to explore the patient's view of the screening trials, implantation and overall use of SCS.
Specialty-Based Variations in Spinal Cord Stimulation Success Rates for Treatment of Chronic Pain
Neuromodulation : journal of the International Neuromodulation Society, 2017
Spinal cord stimulation (SCS) has emerged as an appropriate modality of treatment for intractable chronic pain. The present study examines variations in SCS trial-to-permanent conversion rates based on provider types performing the procedure. We designed a large, retrospective analysis using the Truven MarketScan data base analyzing adult SCS patients with provider information available, with or without IPG implantation from the years 2007-2012. Patients were categorized based on provider type performing the implantation including anesthesiologists, neurosurgeons, orthopedic surgeons, and physical medicine and rehabilitation (PM&R). Univariate and multivariate models identified factors associated with successful conversion. A total of 7667 unique instances of SCS implants were identified across five providers. Overall, 4842 (63.2%) of those receiving trials underwent permanent SCS system implantation. Anesthesiology performed the majority of implants (62.8%), followed by neurosurger...
Spinal Cord Stimulation Has Comparable Efficacy in Common Pain Etiologies
Neuromodulation: Technology at the Neural Interface, 2008
Objectives. The probability of success with spinal cord stimulation (SCS) depends largely on appropriate patient selection. Here, we have assessed the predictive value of pain etiology as it relates to pain relief with SCS as part of a prospective multicenter clinical trial. Methods. Sixty-five subjects with chronic and intractable pain tested an epidural SCS system. Subjects reported pain ratings (visual analog scale) with stimulation off and stimulation on at scheduled follow-up visits for up to 18 months after activation of the system. Visual analog scale scores were averaged and stratified by dominant pain etiologies, comprising failed back surgery syndrome, complex regional pain syndrome, and a subgroup of subjects with miscellaneous other pain etiologies. Results. More than 70% of subjects in each subgroup had successful outcomes during the temporary trial period and similar percentages of subjects from each etiology subgroup subsequently went on to permanent implantation. After permanent implantation, all subgroups reported more than 50% pain relief, on average, at each follow-up time point. No predictive value of pain etiology was obser ved. Conclusions. Spinal cord stimulation is an effective therapy for neuropathic pain arising from a variety of causes. Failed back surger y syndrome, complex regional pain syndrome, and pain of other etiologies responded equally well to SCS.
The Spine Journal, 2001
Background context: Results of subsequent surgical intervention in patients with intractable pain after lumbar spine surgery are typically worse than for initial surgery, particularly in those with predominant complaints of back pain rather than lower extremity pain. Spinal cord stimulation (SCS) has been found to yield good results in patients with primary complaints of intractable lower extremity pain. Technological advances have broadened the indications for this treatment. Purpose: The purpose of this study was to evaluate patient satisfaction after SCS in the treatment of patients with predominant complaints of chronic, intractable, low back pain. Study design/setting: Data were collected from retrospective chart review and patient follow-up questionnaire. Patients were treated at a spine specialty center. Patient sample: The study group consisted of the consecutive series of our first 41 patients who underwent SCS for predominant complaints of low back pain. The mean symptom duration was 82.9 months, and the mean age was 47.9 years (range, 28-83 years). All but three patients had previously undergone lumbar spine surgery (mean, 2.3 prior surgeries). Outcome measures: At the time of follow-up (5.5-19 months after SCS implantation), patients completed questionnaires assessing their satisfaction with their outcome, if they would have the procedure again knowing what their outcome would be and if they would recommend SCS to someone with similar problems. In determining outcome, a negative response was assigned for patients who had the device removed. A worst-case analysis was also conducted in which a negative response was assigned for patients lost to follow-up or who failed to respond to a particular question. Data were also collected on complications and re-operations. Methods: All trial stimulation procedures were performed under local anesthetic with the patient providing feedback concerning pain relief achieved with various lead placements and settings. If one lead did not provide acceptable relief in all the areas needed, placement of a second lead was pursued. If the patient failed to maintain acceptable pain relief (у 50% pain relief) during a multiday trial period, the leads were removed. If adequate relief was maintained during the trial period, the receiver was implanted. Results: Responses to the follow-up questionnaire indicated that 60% of patients considered themselves improved from their preoperative condition and the remaining 40% did not; 78.1% of patients would recommend SCS to someone with similar problems, 69.0% were satisfied, 75.0% would have the procedure performed again if they had known their outcome before implantation. Among the 36 patients in whom the system was implanted, it was later removed in 4 because of lack of sufficient pain relief. Other re-operations included repositioning of the leads to regain pain relief in the areas needed, replacement of a malfunctioning unit and revision of lead extension wires. Conclusions: In this retrospective study, the majority of patients were satisfied with the results of SCS and would have the procedure again knowing what their outcome would be. These results suggest that further investigation of SCS is warranted in this difficult to treat patient population presenting with predominant complaints of chronic, intractable, axial low back pain.