Pain Clinical Trial
Official title:
Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on clinical outcomes during a temporary SCS trial.
The proposed study is a prospective, single-center, two arm, randomized, crossover design to
be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to
include up to 10 subjects in the study. Subjects selected to participate in the trial have
back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a
temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be
followed during the trial period of approximately 7 days.
The study will end when the last subject has completed the trial period. exited. The expected
enrollment period for this study is approximately three months. After exit from the clinical
study, subjects will continue to be followed by their physician per usual care. All device
and procedure-related AEs will be collected and reported per the study protocol.
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