Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain (ESCAPE)

University of Kansas

Status: Enrolling

Conditions: Hypertension; Chronic Pain; Implanted Stimulation Electrodes

Treatments: Diagnostic Test: Diagnostic Tests

Study type: Observational

Funder types: Other

Identifiers

NCT04598035

00145752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 30 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

72 participants in 2 patient groups

Primary Group

Description:

Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device.

Treatment:

Diagnostic Test: Diagnostic Tests

Control Group

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Tests