Automated, patient-interactive, spinal cord stimulator adjustment

A randomized controlled trial

Richard B. North, Sherri Kae Calkins, David S. Campbell, Jeffrey M. Sieracki, Steven Piantadosi, Michael John Daly, P. Bobby Dey, Giancarlo Barolat, Kim J. Burchiel, Louis A. Whitworth, Giovanni Broggi, Yücel Kanpolat, Ali Savas, Meyerson Björn

    Research output: Contribution to journalArticle

    Abstract

    OBJECTIVE: Programmable, multicontact, implanted stimulation devices represent an important advance in spinal cord stimulation for the management of pain. They facilitate the technical goal of covering areas of pain by stimulation-evoked paresthesiae. Adjustment after implantation requires major investments of time and effort, however, if the capabilities of these devices are to be used to full advantage. The objective of maximizing coverage should be met while using practitioners' time efficiently. METHODS: We have developed a patient-interactive, computerized system designed for greater ease and safety of operation, compared with the standard external devices used to control and adjust implanted pulse generators. The system automatically and rapidly presents to the patient the contact combinations and pulse parameters specified by the practitioner. The patient adjusts the amplitude of stimulation and then records drawings of stimulation paresthesiae (for comparison with pain drawings), followed by visual analog scale ratings for each setting. Test results are analyzed and sorted to determine the optimal settings. We compared the automated, patient-interactive system with traditional, practitioner-operated, manual programming methods in a randomized controlled trial at two study centers, with 44 patients. RESULTS: The automated, patient-interactive system yielded significantly (P <0.0001) better technical results than did traditional manual methods, in achieving coverage of pain by stimulation paresthesiae (mean 100-point visual analog scale ratings of 70 and 46, respectively). The visual analog scale ratings were higher for automated testing for 38 patients, higher for manual testing for 0 patients, and equal (tied) for 6 patients. Multivariate analysis demonstrated that the advantage of automated testing occurred independently of practitioner experience; the advantage was significantly greater, however, for experienced patients. The rate of testing (number of settings tested per unit time) was significantly (P <0.0001) greater for the automated system, in comparison with the rate with a human operator using traditional, manual, programming methods (mean of 0.73 settings/min versus 0.49 settings/min). The automated system also identified settings with improved estimated battery life (and corresponding anticipated cost savings). No complications were observed with automated testing; one complication (transient discomfort attributable to excessive stimulation) occurred with manual testing. CONCLUSION: Automated, patient-interactive adjustment of implanted spinal cord stimulators is significantly more effective and more efficient than traditional manual methods of adjustment. It offers not only improved clinical efficacy but also potential cost savings in extending implanted battery life. It has the additional potential advantages of standardization, quality control, and record keeping, to facilitate clinical research and patient care. It should enhance the clinical application of spinal cord stimulation for the treatment of chronic intractable pain.

    Original languageEnglish (US)
    Pages (from-to)572-580
    Number of pages9
    JournalNeurosurgery
    Volume52
    Issue number3
    StatePublished - Mar 1 2003

    Fingerprint

    Social Adjustment
    Spinal Cord
    Randomized Controlled Trials
    Paresthesia
    Visual Analog Scale
    Spinal Cord Stimulation
    Cost Savings
    Pain
    Equipment and Supplies
    Intractable Pain
    Pain Management
    Chronic Pain
    Quality Control
    Pulse
    Patient Care
    Multivariate Analysis

    Keywords

    • Pain drawing
    • Paresthesia mapping
    • Personal computer
    • Spinal cord stimulation

    ASJC Scopus subject areas

    • Clinical Neurology
    • Surgery

    Cite this

    North, R. B., Calkins, S. K., Campbell, D. S., Sieracki, J. M., Piantadosi, S., Daly, M. J., ... Björn, M. (2003). Automated, patient-interactive, spinal cord stimulator adjustment: A randomized controlled trial. Neurosurgery, 52(3), 572-580.

    Automated, patient-interactive, spinal cord stimulator adjustment : A randomized controlled trial. / North, Richard B.; Calkins, Sherri Kae; Campbell, David S.; Sieracki, Jeffrey M.; Piantadosi, Steven; Daly, Michael John; Dey, P. Bobby; Barolat, Giancarlo; Burchiel, Kim J.; Whitworth, Louis A.; Broggi, Giovanni; Kanpolat, Yücel; Savas, Ali; Björn, Meyerson.

    In: Neurosurgery, Vol. 52, No. 3, 01.03.2003, p. 572-580.

    Research output: Contribution to journalArticle

    North, RB, Calkins, SK, Campbell, DS, Sieracki, JM, Piantadosi, S, Daly, MJ, Dey, PB, Barolat, G, Burchiel, KJ, Whitworth, LA, Broggi, G, Kanpolat, Y, Savas, A & Björn, M 2003, 'Automated, patient-interactive, spinal cord stimulator adjustment: A randomized controlled trial', Neurosurgery, vol. 52, no. 3, pp. 572-580.
    North RB, Calkins SK, Campbell DS, Sieracki JM, Piantadosi S, Daly MJ et al. Automated, patient-interactive, spinal cord stimulator adjustment: A randomized controlled trial. Neurosurgery. 2003 Mar 1;52(3):572-580.
    North, Richard B. ; Calkins, Sherri Kae ; Campbell, David S. ; Sieracki, Jeffrey M. ; Piantadosi, Steven ; Daly, Michael John ; Dey, P. Bobby ; Barolat, Giancarlo ; Burchiel, Kim J. ; Whitworth, Louis A. ; Broggi, Giovanni ; Kanpolat, Yücel ; Savas, Ali ; Björn, Meyerson. / Automated, patient-interactive, spinal cord stimulator adjustment : A randomized controlled trial. In: Neurosurgery. 2003 ; Vol. 52, No. 3. pp. 572-580.
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    AU - Sieracki, Jeffrey M.

    AU - Piantadosi, Steven

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    AU - Barolat, Giancarlo

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