Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Change from Baseline Blood Pressure Measurement to 1 week post-op
Study Overview
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:
- 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.
- 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.
- Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from Baseline Blood Pressure Measurement to 1 week post-op
Time Frame: Baseline and 1 week post-op
Measurements of blood pressure via arm cuff and finger cuff
Change from Baseline Blood Pressure Measurement to 8 week post-op
Time Frame: Baseline and 8 week post-op
Measurements of blood pressure via arm cuff and finger cuff
Change from Baseline PainDETECT Questionnaire to 4 week post-op
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
1 week post-op Laboratory Tests
Time Frame: 1 week post-op
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Change from Baseline Blood Pressure Measurement to 4 week post-op
Time Frame: Baseline and 4 week post-op
Measurements of blood pressure via arm cuff and finger cuff
Change from Baseline PainDETECT Questionnaire to 1 week post-op
Time Frame: 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.
4 week post-op Laboratory Tests
Time Frame: 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
Time Frame: 8 week post-op
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Secondary Outcomes
No secondary outcomes reported
Investigators
Seth Holwerda PhD
Principal Investigator
University of Kansas Medical Center