Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain Hypertension Implanted Stimulation Electrodes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 Tests

Intervention Type DIAGNOSTIC_TEST

1. Blood and Urine laboratory tests
2. ECG and blood pressure for cardiovascular measurements
3. 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 Tests

Intervention Type DIAGNOSTIC_TEST

1. Blood and Urine laboratory tests
2. ECG and blood pressure for cardiovascular measurements
3. Self-report questionnaires about pain

Interventions

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Diagnostic Tests

1. Blood and Urine laboratory tests
2. ECG and blood pressure for cardiovascular measurements
3. Self-report questionnaires about pain

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No