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Case Reports
An N-of-1 trial as an aid to decision-making prior to implanting a permanent spinal cord stimulator.
- M Soledad Cepeda, Juan C Acevedo, Hernando Alvarez, Nelcy Miranda, Catalina Cortes, and Daniel B Carr.
- Department of Anesthesia, San Ignacio Hospital, Javeriana University School of Medicine, Bogota, Colombia.
- Pain Med. 2008 Mar 1;9(2):235-9.
ObjectiveLimited 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.DesignCase report.SettingUniversity teaching hospital.PatientsA 61-year-old man patient with refractory postherpetic neuralgia scheduled for SCS implantation.InterventionsPercutaneous 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.Outcome MeasuresAt 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.ConclusionsWe encourage clinicians to perform an N-of-1 trial in every patient before implanting permanent electrodes for SCS.
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