None listed
Conditions
Brief summary
Physical activity is impaired by chronic pain and there is evidence that the distribution of activities over the course of a day varies between persons with chronic low back pain and healthy individuals. Spinal Cord Stimulation can improve chronic pain which can lead to increased physical activity and improved quality of life in chronic pain patients. The objective measures of physical activity may be more useful than self-report to both patients and providers. The incorporation of accelerometry into Spinal Cord Stimulation, aside from allowing adjustment of stimulation in response to the patient’s position, provides the opportunity to objectively measure activity following Spinal Cord Stimulation implantation. Outcomes, including physical activity, should be evaluated using validated instruments to ensure accuracy and reliability. There is a need for the activity measured by the accelerometer imbedded in the Medtronic Intellis Spinal Cord Stimulator to be validated against credible measurements. Accelerometry is considered gold standard for physical activity measurement and the accelerometer imbedded in the disposable Vital Patch has demonstrated validity. The aim of this study is to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Intellis System. Patients who have completed a trial period of spinal cord stimulation and have opted to have a permanent Medtronic Intellis Spinal Cord Stimulator will be recruited into the study. Participants will be asked to wear the VitalPatch, a disposable adhesive device with an embedded accelerometer for five days to collect positional information for comparison with Intellis system. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear. The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase.
Interventions
Spinal Cord Stimulation (SCS) is used to treat patients with chronic lower back and leg pain.
Adult patients with neuropathic back and/or leg pain who are candidates for Medtronic Intellis SCS therapy and who have completed a trial period of spinal cord stimulation and have opted to have a permanent spinal cord stimulator will be recruited into the study. These patients are undergoing standard care for their condition.
The Medtronic Intellis SCS incorporates an accelerometer, which aside fro
Spinal Cord Stimulation (SCS) is used to treat patients with chronic lower back and leg pain. Adult patients with neuropathic back and/or leg pain who are candidates for Medtronic Intellis SCS therapy and who have completed a trial period of spinal cord stimulation and have opted to have a permanent spinal cord stimulator will be recruited into the study. These patients are undergoing standard care for their condition. The Medtronic Intellis SCS incorporates an accelerometer, which aside from allowing adjustments to stimulation in response to patient’s position, provides the opportunity for objective long term assessment of routine physical activity patients with chronic pain. Patients will be asked to wear the VitalPatch, a disposable, adhesive device worn on the upper left chest, which provides continuous monitoring of patient’s health and physiological measurements for five days to collect positional information for comparison with Intellis system. The triaxial accelerometer imbedded in the VitalPatch has demonstrated validity making it suitable for use in validation studies. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear. Patient data from the Vital Patch, in-clinic controlled testing, home wear and diary recording will be used to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Medtronic Intellis SCS. In-clinic controlled testing will be conducted by the study coordinator.
Sponsors
Precision Health Foundation
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. adult patients (18 to 70 years of age) 2. diagnosed with chronic intractable pain of the lower back and/or leg (s) 3. have passed a neuropsychological screen as per standard of care for SCS 4. have opted to undergo permanent SCS implant 5. able to move freely between sitting, standing, lying and walking positions unassisted 6. be willing and capable of giving informed consent 7. be willing and able to comply with study-related requirement, procedures and visits 8. females of childbearing age must have a negative urine pregnancy test at baseline (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
Exclusion criteria
1. have a medical condition or pain in other area (s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 2. have evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact mobility, severe sleep disturbance, compliance of intervention and/or ability to evaluate treatment outcomes 3. have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker 4. have a condition currently requiring or likely to require the use of MRI or diathermy 5. have been diagnosed with a malignancy or has an active systemic infection 6. be pregnant or nursing 7. have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser 8. are under active worker’s compensation (or personal injury) litigation or adjudication
Outcome results
None listed