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

• ClinicalTrials.gov Identifier: NCT02641223
• Recruitment Status: Completed
• First Posted: December 29, 2015
• Last Update Posted: May 30, 2017
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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

Study Design

• 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

Groups and Cohorts

Intervention Details:

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

Lawrence J. Ellison Ambulatory Care Center

Sacramento, California, United States, 95816

Sponsors and Collaborators

University of California, Davis

More Information

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

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations