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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment
Post-laminectomy Syndrome Axial Back Pain Device: spinal cord stimulator

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Intervention Details:
  • Device: spinal cord stimulator
    Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Study Population
Patients presenting to the UCD chronic pain clinic with post-laminectomy syndrome and demonstrate signs of neuropathic axial back pain will be considered. These patients should also be qualified for SCS placement.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, California
Lawrence J. Ellison Ambulatory Care Center
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02641223     History of Changes
Other Study ID Numbers: 7877631
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Back Pain
Postoperative Complications
Spinal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases