Lawrence J. Ellison Ambulatory Care Center
Sacramento, California, 95816, United States
NCT Number: NCT02641223
For this study the investigators will conduct five-day trial periods for spinal cord stimulator (SCS) effectiveness-once a patient is deemed to be a possible SCS candidate, the trial leads are implanted and they are asked to return to clinic in five days to evaluate the effectiveness of the trial. The primary outcome for this study will be a comparison of daily energy expenditure (EE), in units of kcal/day, prior to and after the trial implantation of the SCS leads and external pulse generator. Patients will wear the accelerometer device twenty-four hours a day for five days prior to the trial lead implantation to obtain baseline values, have the trial leads implanted in the procedure clinic, then continue to wear the accelerometer for another five days. Baseline and post-SCS energy expenditure values will be compared. The secondary outcomes for this study will be steps taken, hours of sleep, and Oswestry Disability Index (ODI, as described in appendix 1) during the pre and post trial implantation periods. SCS itself is not a research procedure in this study, rather it is part of routine medical care for patients who would benefit from the procedure.
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Notify Me18 year and older
All sexes
Observational
Sacramento, California, 95816, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.
Time frame: 10 days: change in energy expenditure from 5 days prior to SCS implantation and 5 days post SCS implantation.
Energy expenditure (EE) is measured for five days prior to SCS implantation and the average EE is calculated. After SCS lead implantation, EE is again measured for 5 days and the average EE is calculated. The change in pre and post SCS implantation is examined.
Time frame: 10 days: change in sleep duration between 5 days prior to SCS implantation and 5 days post SCS implantation.
Change in average hours of sleep over a five day period is compared pre and post SCS trial lead implantation.
Time frame: 10 days: change in steps taken between 5 days prior to SCS implantation and 5 days post SCS implantation.
Change in average steps taken over a five day period is compared pre and post SCS trial lead implantation.
University of California, Davis
Other
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