Chronic Pain, Hypertension, Implanted Stimulation Electrodes
Conditions
Brief summary
The purpose of the ESCAPE Study is to determine the extent to which epidural spinal cord stimulation (SCS) reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension. We also aim to determine the extent to which higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS implant. This is an observational study of patients undergoing an implantation of a SCS device.
Detailed description
The broad research goal of this study is to examine the extent to which arterial blood pressure (BP) and blood markers related to hypertension and kidney function are reduced in a prospective cohort of patients undergoing implantation of an epidural spinal cord stimulator (SCS) for the purpose of managing chronic pain in the lower back and/or limbs. Specific aims: 1. Examine the extent to which BP (primary variable), norepinephrine (marker of sympathetic nerve activity in the blood), and a vascular ultrasound scan are improved following the implant of a SCS device among patients with chronic pain and hypertension. 2. Examine the extent to which markers of kidney function in the blood \[serum creatinine, glomerular filtration rate (GFR), and blood urea nitrogen (BUN)\] are reduced following the implant of a SCS device among patients with chronic pain and hypertension. 3. Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.
Interventions
DIAGNOSTIC_TESTDiagnostic Tests
1. Blood and Urine laboratory tests 2. ECG and blood pressure for cardiovascular measurements 3. Self-report questionnaires about pain
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Planning to have an epidural spinal cord stimulation device implanted at KUMC * Male or Female, age 30-89 * Low back pain for more than 3 months * Willing to visit research lab * Willing to undergo a blood draw and blood pressure measures * Able to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Blood Pressure Measurement to 1 week post-op | Baseline and 1 week post-op | Measurements of blood pressure via arm cuff and finger cuff |
| Change from Baseline Blood Pressure Measurement to 4 week post-op | Baseline and 4 week post-op | Measurements of blood pressure via arm cuff and finger cuff |
| Change from Baseline Blood Pressure Measurement to 8 week post-op | Baseline and 8 week post-op | Measurements of blood pressure via arm cuff and finger cuff |
| Change from Baseline PainDETECT Questionnaire to 1 week post-op | Baseline and 1 week post-op. | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Change from Baseline PainDETECT Questionnaire to 4 week post-op | Baseline and 4 week post-op. | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Change from Baseline PainDETECT Questionnaire to 8 week post-op | Baseline and 8 week post-op. | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Baseline Laboratory Tests | Baseline | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane |
| 1 week post-op Laboratory Tests | 1 week post-op | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane |
| 4 week post-op Laboratory Tests | 4 week post-op | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane |
| 8 week post-op Laboratory Tests | 8 week post-op | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane |
Countries
United States
Outcome results
None listed