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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-laminectomy Syndrome Axial Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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spinal cord stimulator

Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes