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Clinical Trials/NCT04598035
NCT04598035Active, not recruitingNot Applicable

Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

University of Kansas Medical Center2 sites in 1 country72 target enrollmentStarted: November 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
72
Locations
2
Primary Endpoint
Change from Baseline Blood Pressure Measurement to 1 week post-op

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from Baseline Blood Pressure Measurement to 1 week post-op

Time Frame: Baseline and 1 week post-op

Measurements of blood pressure via arm cuff and finger cuff

Change from Baseline Blood Pressure Measurement to 8 week post-op

Time Frame: Baseline and 8 week post-op

Measurements of blood pressure via arm cuff and finger cuff

Change from Baseline PainDETECT Questionnaire to 4 week post-op

Time Frame: Baseline and 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.

Change from Baseline PainDETECT Questionnaire to 8 week post-op

Time Frame: Baseline and 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 Laboratory Tests

Time Frame: Baseline

Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane

1 week post-op Laboratory Tests

Time Frame: 1 week post-op

Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane

Change from Baseline Blood Pressure Measurement to 4 week post-op

Time Frame: Baseline and 4 week post-op

Measurements of blood pressure via arm cuff and finger cuff

Change from Baseline PainDETECT Questionnaire to 1 week post-op

Time Frame: Baseline and 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.

4 week post-op Laboratory Tests

Time Frame: 4 week post-op

Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane

8 week post-op Laboratory Tests

Time Frame: 8 week post-op

Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seth Holwerda PhD

Principal Investigator

University of Kansas Medical Center

Study Sites (2)

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