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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Chronic Pain; Implanted Stimulation Electrodes
• Intervention / Treatment: Diagnostic test: Diagnostic Tests

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.

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Seth W Holwerda, PhD; Phone Number: 913-588-5000; Email: sholwerda@kumc.edu

Study Locations

• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Clinical and Translational Science Unit (CTSU)
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Group; 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; Blood and Urine laboratory tests; ECG and blood pressure for cardiovascular measurements; Self-report questionnaires about pain
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.	Diagnostic test: Diagnostic Tests; Blood and Urine laboratory tests; ECG and blood pressure for cardiovascular measurements; Self-report questionnaires about pain

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Seth W Holwerda, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Hypertension; Chronic Pain; Neuralgia
• Other Study ID Numbers: 00145752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No