Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

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.

Official Title
-----------------
Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

Conditions
-----------------
Chronic Pain, Hypertension, Implanted Stimulation Electrodes

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic Tests


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Group<br>Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device. | Diagnostic Test: Diagnostic Tests<br>* Blood and Urine laboratory tests ECG and blood pressure for cardiovascular measurements Self-report questionnaires about pain<br>|
| Control Group<br>Patients with chronic low back pain that are candidates for a surgical implant of a SCS device and do not receive a permanent SCS device after trial leads are placed. | Diagnostic Test: Diagnostic Tests<br>* Blood and Urine laboratory tests ECG and blood pressure for cardiovascular measurements Self-report questionnaires about pain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Blood Pressure Measurement to 1 week post-op | Measurements of blood pressure via arm cuff and finger cuff | Baseline and 1 week post-op | 
| Change from Baseline Blood Pressure Measurement to 4 week post-op | Measurements of blood pressure via arm cuff and finger cuff | Baseline and 4 week post-op | 
| Change from Baseline Blood Pressure Measurement to 8 week post-op | Measurements of blood pressure via arm cuff and finger cuff | Baseline and 8 week post-op | 
| Change from Baseline PainDETECT Questionnaire to 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. | Baseline and 1 week post-op. | 
| Change from Baseline PainDETECT Questionnaire to 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. | Baseline and 4 week post-op. | 
| Change from Baseline PainDETECT Questionnaire to 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 and 8 week post-op. | 
| Baseline Laboratory Tests | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane | Baseline | 
| 1 week post-op Laboratory Tests | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane | 1 week post-op | 
| 4 week post-op Laboratory Tests | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane | 4 week post-op | 
| 8 week post-op Laboratory Tests | Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane | 8 week post-op |