Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

NCT04598035 | Active Not Recruiting

• 1 other identifier: 00145752
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Hypertension; Implanted Stimulation Electrodes

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

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

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

Interventions

Diagnostic Tests DIAGNOSTIC_TEST

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

Control Group; Primary Group

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

University of Kansas Clinical and Translational Science Unit (CTSU)

Fairway, Kansas, 66205, United States

Location

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

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Chronic Pain; Hypertension

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Seth W Holwerda, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (2)