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NCT Number: NCT04598035

Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Cardiovascular Diseases Hypertension Implanted Stimulation Electrodes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Clinical and Translational Science Unit (CTSU), Fairway, Kansas, United States

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About this study

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:

  • 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.
  • 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.
  • Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Diagnostic tests

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Baseline Laboratory Tests

    Time frame: Baseline

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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: ESCAPE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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