Automated, patient-interactive, spinal cord stimulator adjustment: a randomized controlled trial.
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.


CONCLUSIONS
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.
North
Richard B
RB
Department of Neurosurgery, Johns Hopkins University, Baltimore, Maryland 21287-7713, USA. RNorth@jhni.edu
Calkins
Sherri-Kae
SK
Campbell
David S
DS
Sieracki
Jeffrey M
JM
Piantadosi
Steven
S
Daly
Michael John
MJ
Dey
P Bobby
PB
Barolat
Giancarlo
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001331:Automation / Q000295:instrumentation*; D004599:Electric Stimulation Therapy / Q000009:adverse effects* / Q000295:instrumentation*; D004567:Electrodes, Implanted / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000503:physiopathology*; D059408:Pain Management; D010147:Pain Measurement; D017755:Prosthesis Fitting / Q000009:adverse effects* / Q000295:instrumentation*; D012648:Self Care / Q000009:adverse effects* / Q000295:instrumentation*; D013116:Spinal Cord / Q000503:physiopathology*; D013813:Therapy, Computer-Assisted / Q000295:instrumentation