Clinical trial NCT02641223: Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-laminectomy Syndrome
Axial Back Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Change in daily energy expenditure in units of kcal/day.
timeFrame: 10 days: change in energy expenditure from 5 days prior to SCS implantation and 5 days post SCS implantation.
Secondary outcomes:
measure: Change in sleep duration in units of minutes.
timeFrame: 10 days: change in sleep duration between 5 days prior to SCS implantation and 5 days post SCS implantation.
measure: Change in steps taken in units of number of steps.
timeFrame: 10 days: change in steps taken between 5 days prior to SCS implantation and 5 days post SCS implantation.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Lawrence J. Ellison Ambulatory Care Center
state: California
Study officials:
References: