Publications by authors named "Robert Bolash"

27 Publications

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COMBINED BIPOLAR AND V-SHAPED LESIONS FOR LUMBAR FACET RADIOFREQUENCY ABLATION: A TECHNICAL REPORT.

Pain Med 2021 Apr 8. Epub 2021 Apr 8.

Department of Pain Management, Cleveland Clinic, Cleveland, OH.

Introduction: Radiofrequency ablation (RFA) is a demonstrated safe and effective treatment for chronic low back pain. RFA delivers high density electrical current near lumbar medial branch nerve. The success of RFA is contingent upon creating a lesion that overlaps the sensory nerve supplying the affected facet joint(s). Both bipolar-RFA and V-shaped active tip cannulas increase lesion size in experimental models. We describe successful application of concomitant bipolar and V-shaped lesions in a single patient with chronic low back pain caused by lumbar spondylosis.

Case Presentation: An 81-year-old male with atrial fibrillation on chronic warfarin anticoagulation was previously treated with conventional monopolar lumbar facet RFA resulting in a 75% decrement in pain intensity exceeding eight months. Nine months after the procedure, his pain returned with similar pretreatment character and was unresponsive to additional physical therapy and acetaminophen. We elected to use a V-shaped cannula to maximize lesion diameter and lengthen intervals between anticoagulant abstinence to minimize the risk. Intraoperatively, a grounding-pad malfunction compelled us to convert to bipolar-RFA by placing a second adjacent V-shaped cannula, eliminating grounding-pad requirement. Bilateral bipolar medial branch RFA of L3-L4, L4-L5, L5-S1 nerves was performed between these two cannulas without further incident. The patient had sustained analgesia that lasted over twelve months resultant from treatment.

Conclusion: We herein describe a technique of combined bipolar-RFA utilizing proximally adjacent V-shaped cannulas. Both bipolar and V-shaped cannulas create larger lesions in experiments. While both techniques purport theoretical advantages, the clinical superiority of a combined technique warrants continued clinical investigation.
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http://dx.doi.org/10.1093/pm/pnab136DOI Listing
April 2021

Caring from Afar: enabling remote titration of neuromodulation devices.

Authors:
Robert B Bolash

Minerva Anestesiol 2021 May 15;87(5):614-615. Epub 2020 Dec 15.

Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA -

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http://dx.doi.org/10.23736/S0375-9393.20.15248-9DOI Listing
May 2021

Association Between Oral Pain Medications and Intrathecal Opioid Dose Escalation: A Retrospective Analysis.

Neuromodulation 2020 Oct 28;23(7):970-977. Epub 2020 Jun 28.

Department of Pain Management and Evidence Based Pain Research, Cleveland Clinic Foundation, Cleveland, OH, USA.

Objectives: Patients treated with intrathecal therapy frequently require opioid dose increases to maintain analgesia. The kinetics of intrathecal opioid dose escalation are poorly understood. We hypothesized that antidepressant use, antiepileptic use, and lower baseline oral opioid intake prior to intrathecal pump implantation will be protective against intrathecal opioid dose escalation.

Materials And Methods: Targeted drug delivery medication doses were collected from patients who had an intrathecal pump implanted between 2007 and 2016. From a sample size of 136 patients, the association between antidepressant, antiepileptic, and oral opioid use with intrathecal dose escalation was assessed using statistical models.

Results: Individuals using an antiepileptic had an estimated ratio of means (97.5% CI) of opioid consumption of 0.91 (97.5% CI: [0.48, 1.73], p = 0.74) at six months, 0.83 ([0.43, 1.58], p = 0.51) at 12 months, and 0.77 ([0.40, 1.45], p = 0.36) at 24 months. Patients prescribed antidepressants had an estimated ratio of means (97.5% CI) of 1.43 ([0.77, 2.65], p = 0.19) at six months, 1.41 ([0.76, 2.63], p = 0.22) at 12 months, and 1.33 ([0.70, 2.51], p = 0.31) at 24 months. In our secondary analysis of pre-implant oral opioid use, patients treated with high oral opioid doses had a similar pattern of intrathecal dose escalation when compared to patients using low doses of oral opioids.

Conclusions: Use of antiepileptics, antidepressants, or low oral opioid doses was not associated with attenuation of intrathecal dose escalation. Intrathecal opioid dose escalation was observed to occur similarly, regardless of baseline oral analgesics concomitantly employed.
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http://dx.doi.org/10.1111/ner.13214DOI Listing
October 2020

Longevity and Utilization Cost of Rechargeable and Non-Rechargeable Spinal Cord Stimulation Implants: A Comparative Study.

Pain Pract 2020 11 27;20(8):937-945. Epub 2020 Jul 27.

Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, U.S.A.

Introduction: Despite major advancements in features and capabilities of the implantable pulse generator (IPG), real-life longevity and cost-effectiveness studies to guide pain specialists to make the appropriate choice between rechargeable and non-rechargeable IPG are limited. Our study aimed to compare the longevity and cost effectiveness of rechargeable vs. non-rechargeable IPG and SCS systems.

Methods: Data were collected for all SCS implantations performed between 1994 and 2018. The primary goal was to determine IPG longevity, defined as the time interval between IPG implantation and elective replacement due to IPG end of life (EOL). On the other hand, SCS system longevity was defined as the time between SCS implantation and its removal or revision for any reason other than IPG EOL. Kaplan-Meier and log-rank tests were used to assess IPG and SCS system longevities. Cost analysis was performed for cost effectiveness.

Results: The median IPG longevity was significantly higher for rechargeable SCS devices than for non-rechargeable SCS devices (7.20 years and 3.68 years, respectively). The median cost per day was similar for both IPGs, $13.90 and $13.81 for non-rechargeable and rechargeable, respectively. The median cost for SCS systems was higher for the rechargeable group ($60.70) compared with the non-rechargeable group ($31.38).

Conclusions: Rechargeable IPG had increased longevity compared to their non-rechargeable counterparts, yet there was no significant difference in the actual longevity due to premature revisions or explantations between both SCS systems. Furthermore, non-rechargeable SCS systems were found to be the more cost-effective option when compared with rechargeable SCS systems.
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http://dx.doi.org/10.1111/papr.12926DOI Listing
November 2020

Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.

Pain 2020 09;161(9):2068-2078

Pfizer Inc, Groton, CT, United States.

Abstract: This randomized, double-blind, phase 3 study (56-week treatment; 24-week follow-up) assessed tanezumab in patients with chronic low back pain and history of inadequate response to standard-of-care analgesics (NCT02528253). Patients received placebo, subcutaneous tanezumab (5 or 10 mg every 8 weeks), or oral tramadol prolonged-release (100-300 mg/day). Primary endpoint was change in low back pain intensity (LBPI) at week 16 for tanezumab vs placebo. Key secondary endpoints were proportion of patients with ≥50% decrease in LBPI at week 16, change in Roland Morris Disability Questionnaire at week 16, and change in LBPI at week 2 for tanezumab vs placebo. Adverse events and joint safety were assessed through weeks 56 and 80, respectively. Tanezumab 10 mg met the primary endpoint by significantly improving LBPI at week 16 vs placebo; least squares (LS) mean (95% CI) difference = -0.40 (-0.76 to -0.04; P = 0.0281). Tanezumab 10 mg significantly improved all key secondary endpoints. Tanezumab 5 mg did not meet the primary endpoint (LS mean [95% CI] treatment difference vs placebo = -0.30 [-0.66 to 0.07; P = 0.1117]), preventing formal testing of key secondary endpoints for this dose. The proportion of patients with ≥50% improvement in LBPI at week 16 was 37.4% in the placebo group, 43.3% in the tanezumab 5 mg group (Odds ratio [95% CI] vs placebo = 1.28 [0.97 to 1.70; P = 0.0846]), and 46.3% in the tanezumab 10 mg group (Odds ratio [95% CI] vs placebo = 1.45 [1.09 to 1.91; P = 0.0101]). Prespecified joint safety events were more frequent with tanezumab 10 mg (2.6%) than tanezumab 5 mg (1.0%), tramadol (0.2%), or placebo (0%). Seven patients, all in the tanezumab 10 mg group (1.4%), underwent total joint replacement. In conclusion, tanezumab 10 mg significantly improved pain and function vs placebo in patients with difficult-to-treat chronic low back pain. Tanezumab was associated with a low rate of joint safety events, some requiring joint replacement.
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http://dx.doi.org/10.1097/j.pain.0000000000001928DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431140PMC
September 2020

A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain.

Pain Med 2020 11;21(7):1421-1432

Pain Specialists Australia, Richmond, Monash University, Victoria, Australia.

Objective: To conduct a systematic literature review of spinal cord stimulation (SCS) for pain.

Design: Grade the evidence for SCS.

Methods: An international, interdisciplinary work group conducted literature searches, reviewed abstracts, and selected studies for grading. Inclusion/exclusion criteria included randomized controlled trials (RCTs) of patients with intractable pain of greater than one year's duration. Full studies were graded by two independent reviewers. Excluded studies were retrospective, had small numbers of subjects, 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: SCS has Level 1 evidence (strong) for axial back/lumbar radiculopathy or neuralgia (five high-quality RCTs) and complex regional pain syndrome (one high-quality RCT).

Conclusions: High-level evidence supports SCS for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, SCS was more effective than reoperation or medical management. New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional SCS for patients with axial back pain, with or without radicular pain.
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http://dx.doi.org/10.1093/pm/pnz353DOI Listing
November 2020

Choice of spinal cord stimulation versus targeted drug delivery in the management of chronic pain: a predictive formula for outcomes.

Reg Anesth Pain Med 2020 Jan 12. Epub 2020 Jan 12.

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

Contemporary nonmalignant pain treatment algorithms commence with conservative non-invasive strategies, later progressing from minimally invasive interventions to invasive techniques or implantable devices. The most commonly used implantable devices are spinal cord stimulation (SCS) systems or targeted drug delivery (TDD) devices. Historically, SCS had been considered in advance of TDD, positioning TDD behind SCS failures. Following Institutional Review Board approval, data were extracted from electronic medical records of patients who underwent SCS trial in the Department of Pain Management at Cleveland Clinic from 1994 to 2013. The sample size was analyzed in two cohorts: those who succeeded with SCS and those who failed SCS and consequently proceeded to TDD. Univariate and multivariate analyses were performed and a predictive formula for successful outcomes was created. 945 patients were included in the cohort of which 119 (12.6%) subjects achieved adequate pain relief with TDD after failure of SCS. Gender, age, depression and primary pain diagnosis were significantly different in this subgroup. Males were 52% less likely to experience pain relief with SCS. The odds of SCS success decreased as age increased by 6% per year. Patients with comorbid depression, interestingly, were 63% more likely to succeed with SCS. A logistic model was created to predict SCS success which was used to create a predictive formula. Older male patients diagnosed with spine-related pain were more likely to benefit from TDD than SCS. This observation potentially identifies a subgroup in whom consideration for TDD in advance of SCS failure could prove more efficient and cost effective. These retrospective findings warrant prospective comparative studies to validate this derived predictive formula.
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http://dx.doi.org/10.1136/rapm-2019-100859DOI Listing
January 2020

Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.

Neuromodulation 2020 Jan 3;23(1):96-101. Epub 2019 Jun 3.

Stimwave, Inc., Pompano Beach, FL, USA.

Background: "Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely.

Objective: To evaluate fully implanted wireless SCS devices during a 30-day screening trial in subjects with chronic low back pain and leg pain and a history of lumbosacral spine surgery.

Methods: In a randomized controlled trial of single-stage wireless SCS using a wireless percutaneous system, 99 subjects received either 10 kHz high frequency stimulation (HFS) or lower frequency stimulation (LFS) below 1500 Hz (Bolash R, Creamer M, Rauck R, et al. Wireless high frequency spinal cord stimulation (10 kHz) compared to multi-waveform low frequency spinal cord stimulation in the management of chronic pain in failed back surgery syndrome subjects: preliminary results of a multicenter, prospective, randomized controlled study. Pain Med 2019, https://doi.org/10.1093/pm/pnz019). In this report, we assess the 30-day trial success rate (≥50% pain relief from baseline) and complications.

Results: The overall trial success rate was 88% (87/99): 92% (46/50) for HFS and 84% (41/49) for LFS (NS). The trial success rate in the 64 subjects with predominant low back pain was 92% (59/64) vs. 80% (28/35) in those with leg pain ≥ low back pain (NS). During the screening trial, one infection occurred (1%) and one subject withdrew and was explanted (1%). Electrode migrations were seen on routine follow-up x-rays in 10 cases (10%).

Conclusion: Using wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.
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http://dx.doi.org/10.1111/ner.12970DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004134PMC
January 2020

Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study.

Pain Med 2019 10;20(10):1971-1979

Anesthesia Pain Care Consultants, Tamarac, Florida.

Background: This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10-1,500-Hz stimulation (low-frequency [LF]) waveforms.

Methods: Ninety-nine subjects were randomized in a 1:1 ratio to receive either HF or LF stimulation waveforms utilizing the same Freedom WSCS System. All subjects were implanted with two 8-electrode arrays in the exact same anatomical positions within the dorsal epidural spinal column, with the top electrode positioned at the T8 and T9 vertebrae levels, respectively, and the wireless receiver placed under the skin in a subcutaneous pocket.

Results: Seventy-two (HF: N = 38; LF: N = 34) subjects had completed the six-month follow-up after an initial 30-day trial period at the time of this report. For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm. In addition, most subjects experienced significant improvements in VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration.

Conclusions: These preliminary results demonstrate that WSCS devices can reduce FBSS chronic pain substantially with both LF and HF stimulation waveforms over a seven-month period (30-day trial period and six-month post-trial evaluation).
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http://dx.doi.org/10.1093/pm/pnz019DOI Listing
October 2019

Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation.

Reg Anesth Pain Med 2018 Oct;43(7):745-751

Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Background And Objectives: Fascial plane blocks are rapidly emerging to provide safe, feasible alternatives to epidural analgesia for thoracic and abdominal pain. We define a new option for chest wall and upper abdominal analgesia, termed the rhomboid intercostal and subserratus plane (RISS) block. The RISS tissue plane extends deep to the erector spinae muscle medially and deep to the serratus anterior muscle laterally. We describe a 2-part proof-of-concept study to validate the RISS block, including a cadaveric study to evaluate injectate spread and a retrospective case series to assess dermatomal coverage and analgesic efficacy.

Methods: For the cadaveric portion of the study, bilateral ultrasound-guided RISS blocks were performed on 6 fresh cadavers with 30 mL of 0.5% methylcellulose with india ink. For the retrospective case series, we present 15 patients who underwent RISS block or RISS catheter insertion for heterogeneous indications including abdominal surgery, rib fractures, chest tube-associated pain, or postoperative incisional chest wall pain.

Results: In the cadaveric specimens, we identified staining of the lateral branches of the intercostal nerves from T3 to T9 reaching the posterior primary rami deep to the erector spinae muscle medially. In the clinical case series, dermatomal coverage was observed in the anterior hemithorax with visual analog pain scores less than 5 in patients who underwent both single-shot and continuous catheter infusions.

Conclusions: Our preliminary cadaveric and clinical data suggest that RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia.
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http://dx.doi.org/10.1097/AAP.0000000000000824DOI Listing
October 2018

Long-term Outcomes Using Intrathecal Drug Delivery Systems in Complex Regional Pain Syndrome.

Pain Med 2019 03;20(3):515-520

Center for Neurological Restoration.

Objective: Providing durable long-term pain control for patients with complex regional pain syndrome (CRPS) is challenging. A multidisciplinary approach focused on physical therapy is frequently prescribed, with opioids and invasive procedures reserved for those challenged by functional progression. In this study, we examined the long-term efficacy of intrathecal drug delivery systems (IDDS) in patients with CRPS at our institution.

Methods: Patients with CRPS implanted with an IDDS between 2000 and 2013 who had four or more years of continuous follow-up were included in the analysis. The outcome variables of interest were pain intensity and oral opioid intake. The primary predictor of interest was dose of intrathecal opioids, with ziconotide, bupivacaine, and clonidine characterized as binary secondary predictors.

Results: Of the 1,653 IDDS identified, 62 were implanted primarily for CRPS-related pain. Of these, 26 had four or more years of complete follow-up data. Pain scores did not significantly decrease over time, and we observed no correlation between pain intensity and use of any intrathecal medication. Although oral opioid intake decreased over time, intrathecal opioid dose did not affect oral opioid consumption. Ziconotide was associated with a hastening of the decrease in oral opioid intake, whereas the presence of bupivacaine paradoxically increased oral opioid intake.

Conclusions: Our study demonstrates that intrathecal opioid dose was not associated with long-term decreases in oral opioid intake. Additionally, ziconotide was associated with a decrease in oral opioid intake over the four-year follow-up, and bupivacaine was associated with an increase in oral opioid intake. Our study examines the long-term effectiveness of intrathecal medications in managing pain in patients with complex regional pain syndrome. We present a detailed follow-up over four years for 26 patients, tracking oral opiate intake, pain scores, and intrathecal pump settings. Our findings suggest that intrathecal opiates may not be effective in reducing oral opiate intake, ziconotide may hasten a decrease in intake, and bupivacaine may lead to an increase in intake.
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http://dx.doi.org/10.1093/pm/pny104DOI Listing
March 2019

Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant.

Neuromodulation 2017 Aug 17;20(6):543-552. Epub 2017 Jul 17.

Cleveland Clinic, Cleveland, OH, USA.

Introduction: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted.

Methods: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years.

Results: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40).

Discussion: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal.

Conclusions: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.
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http://dx.doi.org/10.1111/ner.12634DOI Listing
August 2017

Efficacy of a Targeted Drug Delivery on-Demand Bolus Option for Chronic Pain.

Pain Pract 2018 03 18;18(3):305-313. Epub 2017 Jul 18.

Departments of Pain Management and Evidence Based Pain Research, Cleveland Clinic, Cleveland, Ohio, U.S.A.

Background And Objectives: Intrathecal targeted drug delivery systems historically required physician office visits for dose adjustment to manage fluctuating pain. A wireless device now enables patients to supplement their basal intrathecal infusion with a programmed on-demand bolus dose. We sought to quantify the change in oral breakthrough opioid need associated with the use of an intrathecal bolus in comparison to those treated with the basal infusion alone.

Methods: Demographic, dosage, bolus usage and longevity data were extracted from the historical medical record of 69 patients (18/51 bolus/nonbolus) followed continuously at our center. Medication consumption and Pain Disability Index measures were obtained at baseline and most recent follow-up.

Results: Among patients with the bolus option, only 2 (11%; confidence interval [CI] 0% to 26%) continued to require oral opiates to manage breakthrough pain compared to 29 (57%; CI 43% to 71%) without the bolus option. The Pain Disability Index score decreased by 19% in patients with the bolus option and by 25% in those with the basal infusion. Total daily intrathecal opioid intake was 34% lower in the group with the bolus device.

Conclusions: Utilizing an intrathecal bolus to treat incident pain was a safe way to manage unpredictable breakthrough pain and may represent a cost-saving opportunity by eliminating the need for oral analgesic medications.
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http://dx.doi.org/10.1111/papr.12602DOI Listing
March 2018

A Comprehensive Outcome-Specific Review of the Use of Spinal Cord Stimulation for Complex Regional Pain Syndrome.

Pain Pract 2017 04 14;17(4):533-545. Epub 2016 Oct 14.

Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, U.S.A.

Background: Complex regional pain syndrome (CRPS) is a painful, debilitating affliction that is often difficult to treat. It has become common international practice to use spinal cord stimulation (SCS) for the treatment of CRPS as other therapies fail to provide adequate relief, quality of life, or improvement in function. This comprehensive outcome-specific systematic review of the use of SCS for CRPS was performed to elucidate the available evidence with focus on clinically relevant patient-specific outcomes.

Methods: A systematic review of the literature was conducted to evaluate the effects of SCS on patients with CRPS for the following outcomes and provide summary levels of evidence in regard to each outcome: perceived pain relief, pain score, resolution of CRPS signs, functional status, quality of life, psychological impact, sleep hygiene, analgesic medication utilization, and patient satisfaction with SCS therapy. Search terms included "complex regional pain syndrome," "spinal cord stimulation," and "reflex sympathetic dystrophy," without restriction of language, date, or type of publication, albeit only original data were included in analyses. Of 30 studies selected, seven systematic reviews were excluded, as were four studies reporting combination therapy that included SCS and other therapies (ie, concurrent peripheral nerve stimulation, intrathecal therapy) without clear delineation to the effect of SCS alone on outcomes. A total of 19 manuscripts were evaluated.

Results: Perceived pain relief, pain score improvement, quality of life, and satisfaction with SCS were all rated 1B+, reflecting positive high-level (randomized controlled trial) evidence favoring SCS use for the treatment of CRPS. Evidence for functional status improvements and psychological effects of SCS was inconclusive, albeit emanating from a randomized controlled trial (evidence level 2B±), and outcomes evidence for both sleep hygiene and resolution of CRPS signs was either nonexistent or of too low quality from which to draw conclusions (evidence level 0). An analgesic sparing effect was observed in nonrandomized reports, reflecting an evidence level of 2C+.

Conclusions: Spinal cord stimulation remains a favorable and effective modality for treating CRPS with high-level evidence (1B+) supporting its role in improving CRPS patients' perceived pain relief, pain score, and quality of life. A paucity of evidence for functional improvements, resolution of CRPS signs, sleep hygiene, psychological impact, and analgesic sparing effects mandate further investigation before conclusions can be drawn for these specific outcomes.
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http://dx.doi.org/10.1111/papr.12513DOI Listing
April 2017

Is Instant Pain Relief Just a Click Away?

Authors:
Robert Bolash

Pain Med 2017 01;18(1):179-180

Departments of Pain Management and Evidence Based Pain Research, Cleveland Clinic, Cleveland, Ohio, USA.

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http://dx.doi.org/10.1093/pm/pnw142DOI Listing
January 2017

Reply to Dr Ruan et al: Are Pain Providers Hostage to Patient Satisfaction Surveys?

Reg Anesth Pain Med 2016 Jul-Aug;41(4):551-2

Department of Pain Management and Department of Evidence Based Pain Research Cleveland Clinic Cleveland, OH Department of Evidence Based Pain Research and Department of Outcomes Research Cleveland Clinic Cleveland, OH.

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http://dx.doi.org/10.1097/AAP.0000000000000426DOI Listing
December 2016

Redirecting Efforts to Achieve Patient Satisfaction in the Chronic Pain Clinic.

Reg Anesth Pain Med 2016 Mar-Apr;41(2):292-3

Department of Pain Management and Evidence Based Pain Research Cleveland Clinic Cleveland, OH Department of Pain Management and Department of Outcomes Research Cleveland Clinic Cleveland, OH.

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http://dx.doi.org/10.1097/AAP.0000000000000362DOI Listing
December 2016

Cost Savings of Patient-Controlled Intrathecal Analgesia.

Authors:
Robert B Bolash

Reg Anesth Pain Med 2015 Sep-Oct;40(5):639-40

Department of Pain Management, Cleveland Clinic, Cleveland, OH.

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http://dx.doi.org/10.1097/AAP.0000000000000281DOI Listing
April 2016

Needle and stylet length discrepancy poses risk.

Authors:
Robert B Bolash

Reg Anesth Pain Med 2015 May-Jun;40(3):294-5

Department of Pain Management Cleveland Clinic Cleveland, OH.

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http://dx.doi.org/10.1097/AAP.0000000000000240DOI Listing
April 2016

Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: a retrospective analysis of 365 patients.

Neuromodulation 2015 Feb 23;18(2):150-5; discussion 155-6. Epub 2014 Sep 23.

Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA.

Objectives: Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified.

Materials And Methods: Patients with an ITP implanted at Cleveland Clinic Pain Management Center between January 1998 and December 2012 were included. ITP longevity was calculated as the time between implant and explant for depletion of the system's battery. Using the 2013 fee schedule of the Centers for Medicare & Medicaid Services, the daily cost of having a functioning ITP was calculated. The costs of office visits for pump refills and the cost of intrathecal medications were not included, nor were the possible savings due to decreased utilization of alternate medical services.

Results: Three hundred sixty-five patients had 559 pumps implanted. Postlaminectomy syndrome was the most common indication (40%). The median system longevity for all pumps was 5.4 years (97.5% confidence interval: [5.0, 5.8]), including pumps extracted prematurely, as well as those that reached the elective replacement interval. The median ITP longevity was 5.9 years (95% confidence interval: [5.6, 6.1]) for pumps explanted for end of battery life. The median system cost per day was $10.46. The median cost per day of pumps explanted for end of battery life was $9.26, versus $44.59 for pumps explanted prematurely due to complications.

Conclusions: Overall, the cohort experienced an increased incidence of pump-related complications and a device longevity that was within the range of the manufacturer's anticipated lifespan. Increasing the lifespan of the ITP and improving patient selection have the potential to significantly improve the cost-effectiveness of intrathecal therapy.
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http://dx.doi.org/10.1111/ner.12235DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4786068PMC
February 2015

Intrathecal pain pumps: indications, patient selection, techniques, and outcomes.

Neurosurg Clin N Am 2014 Oct 13;25(4):735-42. Epub 2014 Aug 13.

Evidence Based Pain Medicine Research, Department of Pain Management, Cleveland Clinic, 9500 Euclid Avenue/C25, Cleveland, OH 44195, USA. Electronic address:

Intrathecal drug delivery represents an advanced modality for refractory chronic pain patients as well as intractable spasticity. This article reviews the advantages and indications for intrathecal therapy, as well as recommendations for proper patient selection using a multidisciplinary team to provide a global assessment of the impact of chronic pain on the patient's well-being. The goals and expectations of trialing are discussed alongside advantages and disadvantages of several trialing techniques. A discussion of outcomes is presented for patients with chronic pain due to both malignant and nonmalignant causes.
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http://dx.doi.org/10.1016/j.nec.2014.06.006DOI Listing
October 2014

Kyphoplasty increases vertebral height, decreases both pain score and opiate requirements while improving functional status.

Pain Pract 2014 Mar 25;14(3):E91-7. Epub 2013 Oct 25.

Department of Pain Management, Cleveland Clinic, Cleveland, Ohio, U.S.A.

Vertebral compression fractures can result from advanced osteoporosis, or less commonly from metastatic or traumatic insults to the vertebral column, and result in disabling pain and decreased functional capacity. Various vertebral augmentation options including kyphoplasty aim at preventing the sequelae of pain and immobility that can develop as the result of the vertebral fractures. The mechanism for pain relief following kyphoplasty is not entirely understood, and the restoration of a portion of the lost vertebral height is a subject of debate. We retrospectively reviewed radiographic imaging, pain relief, analgesic intake and functional outcomes in 67 consecutive patients who underwent single- or multilevel kyphoplasty with the primary goal of quantifying the restoration of lost vertebral height. We observed a mean of 45% of the lost vertebral height restored postprocedurally. Secondarily, kyphoplasty was associated with significant decreases in pain scores, daily morphine consumption and improvement in patient-reported functional measures.
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http://dx.doi.org/10.1111/papr.12131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3949154PMC
March 2014

Improving guideline compliance: assessment of unit-based reminder for monitoring platelet counts post-PCI.

J Healthc Qual 2002 Jan-Feb;24(1):9-14; quiz 14, 48

St. Lukes Hospital, USA.

In assessing our institution's vascular access site bleeding complication rate, we found (anecdotally) that for many patients platelet count was not measured according to recommendations of the manufacturer of the predominantly used glycoprotein (GP) IIb/IIIa agents, in either the catheterization recovery unit (CRU) or the coronary care unit (CCU). We hypothesized that a unit-focused effort to remind cardiologists to order platelet counts after percutaneous coronary interventions GP IIb/IIIa would improve compliance. Findings indicated that a greater number of patients had platelet counts drawn after a reminder effort had been implemented. For both the first and second draws, the CCU had a higher pre-reminder rate than the CRU. Post-reminder, the CCU had no significant changes, whereas the CRU showed significant increases in both the first and second draws. For post GP IIb/IIIa platelet measurement, aggregate analysis (CRU and CCU) showed that, of those patients who had platelet counts drawn pre-reminder, only 18.2% met the first guideline and only 17.1% met the second. Post-reminder results showed no significant changes for the first or second draws. We concluded that the practical application of a standard operating procedure can have a secondary beneficial effect despite not meeting the stringent parameters set in prescribing guidelines.
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http://dx.doi.org/10.1097/01445442-200201000-00003DOI Listing
February 2002