Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

Hypertension Clinical Trial

— ESCAPE  

Official title:

Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598035
• Other study ID #: 00145752
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2021
• Source: University of Kansas Medical Center
• Contact: Seth W Holwerda, PhD
• Phone: 913-588-5000
• Email: sholwerda[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Hypertension
• Implanted Stimulation Electrodes
• Neuralgia

Intervention

Diagnostic Test:
• Diagnostic Tests
Blood and Urine laboratory tests ECG and blood pressure for cardiovascular measurements Self-report questionnaires about pain

Locations

Country	Name	City	State
United States	University of Kansas Clinical and Translational Science Unit (CTSU)	Fairway	Kansas
United States	The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	Baseline Laboratory Tests	Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane	Baseline
Primary	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
Primary	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
Primary	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