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

NCT02641223 | Completed

• 1 other identifier: 7877631
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-laminectomy Syndrome; Axial Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in sleep duration in units of minutes.

  10 days: change in sleep duration between 5 days prior to SCS implantation and 5 days post SCS implantation.

• Change in steps taken in units of number of steps.

  10 days: change in steps taken between 5 days prior to SCS implantation and 5 days post SCS implantation.

Interventions

spinal cord stimulator DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients presenting to the UCD chronic pain clinic with post-laminectomy syndrome and demonstrate signs of neuropathic axial back pain will be considered.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Lawrence J. Ellison Ambulatory Care Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

post laminectomy syndrome

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)