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

Tracking Information

• First Submitted Date: December 16, 2015
• First Posted Date: December 29, 2015
• Last Update Posted Date: May 30, 2017
• Study Start Date: November 2015
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 22, 2015)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation
• Official Title: Not Provided
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Post-laminectomy Syndrome
• Axial Back Pain

Intervention

Device: spinal cord stimulator

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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2017): 9
• Original Estimated Enrollment (submitted: December 22, 2015): 18
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02641223
• Other Study ID Numbers: 7877631
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, Davis
• Original Responsible Party: Samir Sheth, MD, University of California, Davis, Associate Professor
• Current Study Sponsor: University of California, Davis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of California, Davis
• Verification Date: May 2017