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      10 kHz spinal cord stimulation: a retrospective analysis of real-world data from a community-based, interdisciplinary pain facility

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          Abstract

          Objective

          To evaluate clinical outcomes and health care utilization at 12 months post spinal cord stimulator (SCS) implantation compared with baseline and a matched sample of patients receiving conventional medical management (CMM) for the treatment of low back and lower extremity pain.

          Patients

          A retrospective study of patients with at least 24 months of active treatment at an interdisciplinary community pain center between December 1, 2014 and December 31, 2017. Thirty-two patients receiving implantation of a high-frequency (10 kHz) SCS and 64 patients receiving CMM were identified through propensity matching at a ratio of 2:1.

          Methods

          Data were extracted from medical records, including pain severity, prescribed opioid dose in morphine milligram equivalents, patient perception of disability, and volume of interventional pain procedures and total office visits to the pain center.

          Results

          Reductions in opioid dose were significantly greater for the SCS group than the CMM group. The 26.2 mg morphine equivalent dose reduction represents a 28% reduction from baseline, with 71.4% of those prescribed opioids in the SCS group reducing their dose at 12 months post-implant. Among those with SCS, there were significant within-group reductions in numerical pain score for low back and lower extremity pain, reducing by 46.2% and 50.9% from baseline, respectively. Change in functional pain score was not significant for either SCS group or CMM. Both groups had significant within-group reduction in disability. Reduction of interventional procedure volume was significant for both groups with a greater reduction observed in the SCS group. Office visit volume reduction was significant for the CMM group, but this was not a significant difference from the SCS group.

          Conclusions

          Results support the efficacy of 10 kHz SCS for analgesia, reduction of opioid utilization, reduction of interventional pain procedures, and patient perception of disability.

          Related collections

          Most cited references 29

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          The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms.

          Somatization is prevalent in primary care and is associated with substantial functional impairment and healthcare utilization. However, instruments for identifying and monitoring somatic symptoms are few in number and not widely used. Therefore, we examined the validity of a brief measure of the severity of somatic symptoms. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-15 comprises 15 somatic symptoms from the PHQ, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The PHQ-15 was administered to 6000 patients in eight general internal medicine and family practice clinics and seven obstetrics-gynecology clinics. Outcomes included functional status as assessed by the 20-item Short-Form General Health Survey (SF-20), self-reported sick days and clinic visits, and symptom-related difficulty. As PHQ-15 somatic symptom severity increased, there was a substantial stepwise decrement in functional status on all six SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. PHQ-15 scores of 5, 10, 15, represented cutoff points for low, medium, and high somatic symptom severity, respectively. Somatic and depressive symptom severity had differential effects on outcomes. Results were similar in the primary care and obstetrics-gynecology samples. The PHQ-15 is a brief, self-administered questionnaire that may be useful in screening for somatization and in monitoring somatic symptom severity in clinical practice and research.
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            Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial.

            Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain.
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              • Article: not found

              Factor structure, reliability, and validity of the Pain Catastrophizing Scale.

              The Pain Catastrophizing Scale (PCS; Sullivan et al., Psychol. Assess. 7, 524-532, 1995) has recently been developed to assess three components of catastrophizing: rumination, magnification, and helplessness. We conducted three studies to evaluate the factor structure, reliability, and validity of the PCS. In Study I, we conducted principal-components analysis with oblique rotation to replicate the three factors of the PCS. Gender differences on the original PCS subscales were also analyzed. In Study II, we conducted confirmatory factor analyses to evaluate the adequacy of fit of four alternative models. We also evaluated evidence for concurrent and discriminant validity. In Study III, we evaluated the ability of the PCS and subscales to differentiate between the responses of clinic (students seeking treatment) and nonclinic undergraduate samples. Also, in the clinic sample, we evaluated evidence of concurrent and predictive validity for the PCS. The internal consistency reliability indices for the total PCS and subscales were examined in all three studies. Limitations and future directions are discussed.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2018
                20 November 2018
                : 11
                : 2929-2941
                Affiliations
                [1 ]Boston PainCare, Waltham, MA, USA, Michael.Schatman@ 123456tufts.edu
                [2 ]Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, MA, USA
                [3 ]Department of Public Health and Community Medicine, Tufts School of Medicine, Boston, MA, USA, Michael.Schatman@ 123456tufts.edu
                [4 ]Department of Anesthesia Critical Care and Pain Medicine, Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA
                [5 ]Division of Biostatistics and Experimental Design, Tufts School of Dental Medicine, Boston, MA, USA
                Author notes
                Correspondence: Michael E Schatman, Boston PainCare, 85 First Avenue, Waltham, MA 02451, USA, Tel +1 425 647 4880, Email Michael.Schatman@ 123456tufts.edu
                Article
                jpr-11-2929
                10.2147/JPR.S188795
                6251433
                © 2018 DiBenedetto et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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