NCT02641223

Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Post-laminectomy Syndrome
• Axial Back Pain

Interventions

Type	Name	Description
DEVICE	spinal cord stimulator	Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-12-29
• Last updated: 2017-05-30

Locations

1 site across 1 country: United States