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



Status:Completed
Conditions:Back Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:3/31/2017
Start Date:November 2015
End Date:December 2016

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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.


Inclusion Criteria:

- Patients presenting to the UCD chronic pain clinic with post-laminectomy syndrome and
demonstrate signs of neuropathic axial back pain will be considered.

Exclusion Criteria:

- 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.
We found this trial at
1
site
Sacramento, California 95816
Phone: 916-734-7246
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Sacramento, CA
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