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

Post-laminectomy Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641223
• Other study ID #: 7877631
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: May 24, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Axial Back Pain
• Back Pain
• Post-laminectomy Syndrome
• Postoperative Complications
• Spinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Lawrence J. Ellison Ambulatory Care Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily energy expenditure in units of kcal/day.	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.	10 days: change in energy expenditure from 5 days prior to SCS implantation and 5 days post SCS implantation.
Secondary	Change in sleep duration in units of minutes.	Change in average hours of sleep over a five day period is compared pre and post SCS trial lead implantation.	10 days: change in sleep duration between 5 days prior to SCS implantation and 5 days post SCS implantation.
Secondary	Change in steps taken in units of number of steps.	Change in average steps taken over a five day period is compared pre and post SCS trial lead implantation.	10 days: change in steps taken between 5 days prior to SCS implantation and 5 days post SCS implantation.