NCT04598035

Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Hypertension
• Implanted Stimulation Electrodes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic Tests	1. Blood and Urine laboratory tests 2. ECG and blood pressure for cardiovascular measurements 3. Self-report questionnaires about pain

Timeline

• Start date: 2020-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2020-10-22
• Last updated: 2025-08-07

Locations

2 sites across 1 country: United States