Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation
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|ClinicalTrials.gov Identifier: NCT02641223|
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : May 30, 2017
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|Condition or disease||Intervention/treatment|
|Post-laminectomy Syndrome Axial Back Pain||Device: spinal cord stimulator|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Device: spinal cord stimulator
Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.
- Change in daily energy expenditure in units of kcal/day. [ 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.
- Change in sleep duration in units of minutes. [ 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.
- Change in steps taken in units of number of steps. [ 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Patients presenting to the UCD chronic pain clinic with post-laminectomy syndrome and demonstrate signs of neuropathic axial back pain will be considered.
- Adults unable to consent, individuals who are not yet adults, pregnant women, patients unable to stop anticoagulation, and prisoners will be excluded.
- Pregnant patients will be excluded due to the risks of radiation exposure during SCS procedures and prisoners will be excluded as our clinic does not receive referrals from prison populations at this time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641223
|United States, California|
|Lawrence J. Ellison Ambulatory Care Center|
|Sacramento, California, United States, 95816|
|Responsible Party:||University of California, Davis|
|Other Study ID Numbers:||
|First Posted:||December 29, 2015 Key Record Dates|
|Last Update Posted:||May 30, 2017|
|Last Verified:||May 2017|