The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
Study Type
OBSERVATIONAL
Enrollment
12
This system remains in place up to 60 days, then removed.
Aurora Health Center
Fond du Lac, Wisconsin, United States
Aurora Health Oshkosh
Oshkosh, Wisconsin, United States
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Time frame: up to 60 days post lead placement
Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.
Time frame: up to 60 days post lead placement
Average change from baseline to end of treatment in pain interference measured through BPI-SF.
Time frame: up to 60 days post lead placement
Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)
Time frame: up to 60 days post lead placement
Overall patient global impression of change (PGIC) at end of treatment.
Time frame: up to 60 days post lead placement
Overall incidence of lead migration/fracture at the end of treatment.
Time frame: up to 60 days post lead placement
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
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Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Overall patient global impression of change (PGIC) at 6 months and end of study.
Time frame: 6 and 12 months post lead pull
Overall incidence of lead migration/fracture during the study.
Time frame: 12 months