An N-of-1 trial as an aid to decision-making prior to implanting a permanent spinal cord stimulator.
OBJECTIVE
Limited evidence supports the efficacy of spinal cord stimulation (SCS). Therefore, it is crucial to assess the usefulness of this invasive procedure before implanting permanent electrodes in each patient. An N-of-1 trial is an experiment in which a single participant undergoes periods of comparative treatments. We illustrate how an N-of-1 trial design may permit clinicians to conduct such an assessment in an individual patient.


METHODS
Case report.


METHODS
University teaching hospital.


METHODS
A 61-year-old man patient with refractory postherpetic neuralgia scheduled for SCS implantation.


METHODS
Percutaneous octapolar lead placement into the epidural space for SCS at T5-T6, and placement of transcutaneous electrical nerve stimulator (TENS) electrodes upon the painful area on the patient's back. We provided electrical stimulation via TENS or SCS according to a computer-generated random number list. Each stimulation period lasted 5 hours, followed by 1 hour of rest.


METHODS
At the end of each period, a blinded assessor evaluated the degree of pain relief, pain intensity, area of stimulation, and the patient's satisfaction. The study had a 5-day duration. Results. In this patient, spinal stimulation was equally efficacious as TENS.


CONCLUSIONS
We encourage clinicians to perform an N-of-1 trial in every patient before implanting permanent electrodes for SCS.
Cepeda
M Soledad
MS
Department of Anesthesia, San Ignacio Hospital, Javeriana University School of Medicine, Bogota, Colombia.
Acevedo
Juan C
JC
Alvarez
Hernando
H
Miranda
Nelcy
N
Cortes
Catalina
C
Carr
Daniel B
DB
D003657:Decision Making; D004599:Electric Stimulation Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000628:therapy*; D013116:Spinal Cord; D016896:Treatment Outcome