Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

Last updated: August 5, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Williams Syndrome

Vascular Diseases

Pain (Pediatric)

Treatment

Diagnostic Tests

Clinical Study ID

NCT04598035
00145752
  • Ages 30-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • 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

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Diagnostic Tests
Phase:
Study Start date:
November 01, 2020
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • University of Kansas Clinical and Translational Science Unit (CTSU)

    Fairway, Kansas 66205
    United States

    Site Not Available

  • The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

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