scholarly journals Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Chronic Pain

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. 1-12
Author(s):  
David Schultz
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Adverse Events ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Body Position ◽  
Primary Objective ◽  
Position Sensing ◽  
Manual Adjustment ◽  
Patient Reported

Background: Variation in the intensity of neurostimulation due to body position is a practical problem for many patients implanted with spinal cord stimulation (SCS) systems because positional changes may result in overstimulation or understimulation that leads to frequent need for compensatory manual programming adjustments. Objectives: The purpose of this study was to assess the safety and effectiveness of a novel type of SCS therapy designed to automatically adapt stimulation amplitude in response to changes in a patient’s position or activity. The primary objective of the study was to demonstrate that automatic position-adaptive SCS benefited patients in terms of pain relief and/or convenience compared with neurostimulation adjusted with conventional manual programming. Secondary objectives included assessment of worsened pain relief with automatic adjustment; change in pain score; and the number of manual programming adjustments with position-adaptive neurostimulation compared with manual programming. Study Design: Prospective, multicenter, open-label, randomized crossover study. Setting: Ten interventional pain management centers in the US. Methods: Patients were enrolled a minimum of one week after a successful SCS screening trial. They were then implanted with the RestoreSensorTM neurostimulation device (Medtronic, Inc., Minneapolis, MN) that could be programmed to either automatic position-adaptive stimulation (AdaptiveStimTM) or manual adjustment of stimulation parameters. After implant, all devices were programmed to conventional manual adjustment for a 4-week postoperative period. The patients were then randomized to either conventional manual programming adjustment or position-adaptive stimulation with crossover to the opposite treatment arm occurring at 6 weeks after randomization. The patients were followed for another 6 weeks after crossover. This study was conducted under an FDA-approved Investigational Device Exemption (IDE) and approval of the responsible Institutional Review Boards (IRBs) of the study centers. Results: Seventy-nine patients were enrolled in the study. In an intent-to-treat analysis, 86.5% of patients achieved the primary objective of improved pain relief with no loss of convenience or improved convenience with no loss of pain relief using automatic position-adaptive stimulation compared with using conventional manual programming adjustment alone. This was statistically significantly greater than the predefined minimum success rate of 25%, P < 0.001 (exact one-sided 97.5% lower confidence limit was 76.5%). Only 2.8% of patients reported worsened pain relief during position-adaptive stimulation compared with manual programming. There was a statistically significant reduction in the mean numeric pain rating scale score compared with baseline scores in both treatment arms. Additionally, position-adaptive stimulation demonstrated a statistically significant 41% reduction in the daily average number of programming button presses for amplitude adjustment compared with manual programming (18.2 per day versus 30.7 per day, P = 0.002). Functional improvements reported with position-adaptive stimulation included: improved comfort during position changes (80.3%); improved activity (69%); and improved sleep (47.9%). Adverse events associated with uncomfortable sensations from stimulation did not differ significantly between treatment arms. The incidence of device-related serious adverse events was 3.9%. Limitations: Patients and physicians were not blinded to whether devices were programmed to automatic position-adaptive stimulation or manual adjustment. Responses to assessment questionnaires were based on patient recall. Conclusions: The study demonstrated that automatic position-adaptive stimulation is safe and effective in providing benefits in terms of patient-reported improved pain relief and convenience compared with using manual programming adjustment alone. Key words: spinal cord stimulation, neurostimulation, position sensing, physical activity accelerometer, neuromodulation, effectiveness, pain relief, position-adaptive stimulation, posture-adaptive stimulation, AdaptiveStim Clinical Trial: NCT01106404

scholarly journals High Frequency Spinal Cord Stimulation in a Patient with Bilateral Cochlear Implants

2021 ◽  
pp. 189-191
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Pain Clinic ◽  
Bilateral Cochlear Implants ◽  
Patient Reported

BACKGROUND: High-frequency spinal cord stimulation (HF-SCS) has become very popular in the management of chronic pain worldwide. As it relies on generating high-frequency electrical impulses, there is a risk of interference with other devices such as cochlear implants that utilize similar principles. A literature search did not reveal any case reports of HF-SCS implantation in a patient with cochlear implants. CASE REPORT: A 75-year-old White woman with a history of bilateral cochlear implants (Cochlear Americas Nucleus® with cp910 processor) for severe sensorineural hearing loss presented to our chronic pain clinic with lumbosacral radiculopathy. The patient underwent a HF-SCS trial with entry point at the L1-L2 space and the leads positioned at the top and bottom of T8. The patient did not experience any auditory interference with her Cochlear implant at triple the average SCS stimulation strength. During the follow-up visit the next week, the patient reported nearly 80% symptomatic pain relief and significant functional improvement. There was no change in her hearing and no evidence of interference. The patient ultimately underwent percutaneous SCS paddle electrode placement and at 3 months, continues to have excellent pain relief without any auditory interactions. CONCLUSION: We successfully implanted a HF-SCS at the thoracic level in a patient with bilateral cochlear implants without any auditory interference. KEY WORDS: Cochlear implant, lumbar radiculopathy, spinal cord stimulation

Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials

2021 ◽  
pp. rapm-2020-102238
Author(s):  
Jonathan M Hagedorn ◽  
Timothy R Deer ◽  
Nicholas C Canzanello ◽  
Stephen M Covington ◽  
Darrell R Schroeder ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Pain Scale ◽  
Concordance Correlation ◽  
Percentage Improvement ◽  
Patient Reported ◽  
The Mean ◽  
Numeric Rating

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

scholarly journals Automatic Adaptation of Neurostimulation Therapy in Response to Changes in Patient Position: Results of the Posture Responsive Spinal Cord Stimulation (PRS) Research Study

2011 ◽  
Vol 5;14 (5;9) ◽  
pp. 407-417
Author(s):  
Cristy M. Schade
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Body Position ◽  
Leg Pain ◽  
Test Protocol ◽  
Automatic Adjustment ◽  
Patient Position ◽  
Manual Adjustment ◽  
Stimulation System ◽  
Stimulation Amplitude

Background: Variation in the intensity of neurostimulation with body position is a practical problem for many patients implanted with a spinal cord stimulation system because positional changes may result in overstimulation or understimulation. These posture-related changes in patients’ perception of paresthesia can affect therapeutic outcomes of spinal cord stimulation therapy. An accelerometer-based algorithm that automatically adjusts spinal cord stimulation based on sensed body position or activity represents a potential solution to the problem of position-mediated variations in paresthesia perception. Objective: The objective of this study was to compare patient satisfaction ratings for manual versus automatic adjustment of spinal cord stimulation amplitude in response to positional changes. Study Design: Prospective, multicenter, open-label, randomized trial Setting: 2 pain centers in the US. Method: Twenty patients at 2 centers in the U.S. who had been implanted with a spinal cord stimulation system for low back and/or leg pain were enrolled in the study. During a 3-day run-in phase, patient position and activity changes were monitored with an ambulatory data recorder and with a research patient programmer which recorded all stimulation parameter changes. Patients who made ≥ 2 amplitude adjustments per 24- hour period were invited to participate in an in-clinic phase. During the in-clinic phase, patients’ preferred stimulation amplitude and therapy impedance measured at the preferred stimulation amplitude were determined as they performed a series of 8 physical tasks. Satisfaction ratings were determined during position transitions between the physical tasks using both manual and automatic adjustments. Results: Among the 15 patients who completed the in-clinic test protocol, overall satisfaction ratings were significantly higher for automatic adjustment of stimulation amplitudes versus manual adjustments. Patients reported statistically significant improvements with automatic versus manual adjustment for the standing to supine transition and for supine to standing transition. Approximately 74% of participants rated the paresthesia intensity of the automatic adjustment algorithm as “just right” for the physical tasks that were completed. Limitations: Small study size. Conclusion: Patients preferred automatic versus manual adjustment of stimulation amplitude in response to changes in paresthesia consequent to positional changes during in-clinic testing. Key words: spinal cord stimulation, automaticity, paresthesia, neuromodulation, neurostimulation, adaptive stimulation, posture responsive stimulation, accelerometry

scholarly journals A Case of Spinal Cord Stimulation in Raynaud’s Phenomenon: Can Subthreshold Sensory Stimulation Have an Effect?

2007 ◽  
Vol 3;10 (5;3) ◽  
pp. 473-478
Author(s):  
Ramsin Benyamin
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Raynaud’S Phenomenon ◽  
Stellate Ganglion ◽  
Stellate Ganglion Block ◽  
Sensory Perception ◽  
Raynaud's Phenomenon ◽  
Spinal Cord Stimulator ◽  
Patient Reported

Spinal cord stimulation is currently used to treat a variety of chronic intractable painful conditions. We report a case of severe Raynaud’s phenomenon in the hands refractory to conservative treatment and responsive to diagnostic stellate ganglion block that was effectively treated with a spinal cord stimulator placed in the cervical epidural space. After capturing the affected areas with paresthesias, blood flow in the left hand and fingers significantly improved as evidenced by an increase in skin temperature, a change from cyanotic to pink appearance and concomitant reduction in pain. Moreover, the patient reported that limb ischemia and pain could be managed overnight with stimulation intensities that were below sensory perception thresholds. Thus it seems, at least in the overnight period, paresthesias were not required to maintain pain relief. This case presents a potential divergence between a requirement for paresthesias and pain relief in spinal cord stimulation therapy for the treatment of Raynaud’s phenomenon. The possible role of the sympathetic nervous system in this relationship is also discussed. Key words: spinal cord stimulator, Raynaud’s phenomenon, sensory perception

Spinal Cord Stimulation: A Contemporary Series

Neurosurgery ◽  
1991 ◽  
Vol 28 (1) ◽  
pp. 65-71 ◽  
Author(s):  
Roberto Spiegelmann ◽  
William A. Friedman
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Literature Review ◽  
General Anesthesia ◽  
Detailed Analysis ◽  
Spinal Cord Stimulation ◽  
Significant Pain ◽  
Experience Pain

Abstract Forty-three patients with chronic pain disorders of different causes were selected for spinal cord stimulation. All underwent implantation of a ribbon electrode through a small laminotomy, under general anesthesia. Thirteen patients (30%) failed to obtain significant pain relief during a period of trial stimulation, and their electrodes were removed. The remainder underwent a definitive implant and were followed for a mean of 13 months (range, 3-33 months). Nineteen of them (63%) continued to experience pain relief. A detailed analysis of this series, as well as a literature review, is presented.

scholarly journals Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

2021 ◽  
Author(s):  
Ganesan Baranidharan ◽  
Beatrice Bretherton ◽  
Craig Montgomery ◽  
John Titterington ◽  
Tracey Crowther ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Spinal Cord Stimulation ◽  
Meta Analysis ◽  
Safety Outcomes

Increased Pain Catastrophizing Associated With Lower Pain Relief During Spinal Cord Stimulation: Results From a Large Post-Market Study

2015 ◽  
Vol 18 (4) ◽  
pp. 277-284 ◽  
Author(s):  
Jason C. Rosenberg ◽  
David M. Schultz ◽  
Luis E. Duarte ◽  
Steven M. Rosen ◽  
Adil Raza
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Pain Catastrophizing ◽  
Post Market ◽  
Lower Pain

scholarly journals Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Minji K. Lee ◽  
Benjamin D. Schalet ◽  
David Cella ◽  
Kathleen J. Yost ◽  
Amy C. Dueck ◽  
...  
Keyword(s):  
Information System ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Measurement Information ◽  
Outcomes Measurement ◽  
T Score ◽  
Patient Reported ◽  
Measurement Information System ◽  
The Common

Abstract Background Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another. Methods Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0–10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1–5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking. Results In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0. Conclusion We produced robust linking between single item symptom measures and PROMIS short forms.

Defining minimal clinically important differences in pain and disability outcomes of patients with chronic pain treated with spinal cord stimulation

2021 ◽  
pp. 1-8
Author(s):  
Shelby Sabourin ◽  
Justin Tram ◽  
Breanna L. Sheldon ◽  
Julie G. Pilitsis
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Pain Catastrophizing ◽  
Pain Syndrome ◽  
Failed Back Surgery Syndrome ◽  
Mcgill Pain Questionnaire ◽  
Minimum Detectable Change ◽  
Failed Back Surgery

OBJECTIVE Minimal clinically important difference (MCID) thresholds for a limited number of outcome metrics were previously defined for patients with failed back surgery syndrome (FBSS) at 6 months after spinal cord stimulation (SCS). This study aimed to further define MCID values for pain and disability outcomes. Additionally, the authors established 1-year MCID values for outcome measures with previously defined metrics commonly used to assess SCS efficacy. METHODS Preoperative and 1-year postoperative outcomes were collected from 114 patients who received SCS therapy for FBSS, complex regional pain syndrome, and neuropathic pain. MCID values were established for the numerical rating scale (NRS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), McGill Pain Questionnaire (MPQ), and Pain Catastrophizing Scale (PCS). Four established anchor-based methods were utilized to compute MCID values with two anchored questions: “Are you satisfied with SCS therapy?” and “Would you have SCS surgery again?” For each question, patients were categorized as responders if they answered “yes” or as nonresponders if they responded “no.” The methodologies utilized to compute MCID scores included the average change method, minimum detectable change approach, change difference calculation, and receiver operating characteristic (ROC) analysis. Area under the ROC curve (AUC) analysis has been shown to inform the accuracy at which the MCID value can distinguish responders from nonresponders and was analyzed for each instrument. RESULTS For the first time, ranges of MCID values after SCS were established for MPQ (1–2.3) and PCS (1.9–13.6). One-year MCID values were defined for all indications: NRS (range 0.9–2.7), ODI (3.5–6.9), and BDI (2–5.9). AUC values were significant for NRS (0.78, p < 0.001), ODI (0.71, p = 0.003), MPQ (0.74, p < 0.001), and PCS (0.77, p < 0.001), indicating notable accuracy for distinguishing satisfied patients. CONCLUSIONS This was the first study to successfully determine MCID values for two prominent instruments, MPQ and PCS, used to assess pain after SCS surgery. Additionally, previously established MCID values for ODI, BDI, and the visual analog scale for patients with FBSS at 6 months after treatment were explored at 12 months for the most common indications for SCS. These data may better inform physicians of patient response to and success with SCS therapy.

scholarly journals Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study

2012 ◽  
Vol 109 (5) ◽  
pp. 837 ◽  
Author(s):  
W.A. Pluijms ◽  
R Slangen ◽  
M Bakkers ◽  
C.G. Faber ◽  
I.S.J. Merkies ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Pilot Study ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Diabetic Polyneuropathy ◽  
Life Improvement
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