Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
Purpose
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.
Conditions
- Chronic Pain
- Hypertension
- Implanted Stimulation Electrodes
Eligibility
- Eligible Ages
- Between 30 Years and 89 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Primary Group | Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device. |
|
| Control Group | 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. |
|
Recruiting Locations
Fairway, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center
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.