Chronic PainESCAPENCT04598035

Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

An observational study of Chronic Pain and Hypertension, run by University of Kansas Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 30 to 89 years
Conditions the study is for: Chronic Pain, Hypertension, Implanted Stimulation Electrodes
What is being tested?: Diagnostic Tests
How many people: 72 participants
Where: 2 sitesUnited States
Study dates: 1 Nov 2020to 1 Nov 2025
How long will I take part?: 2 Months
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kansas Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, 66205
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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.

Read the 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:

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.

Conditions: Chronic Pain, Hypertension, Implanted Stimulation Electrodes
Being tested: Diagnostic Tests
Medical subject headings: Chronic Pain, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04598035
Study group	Role	What they receive
Primary Group		Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device. Receives: 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. Receives: Diagnostic Test: Diagnostic Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Blood Pressure Measurement to 1 week post-op
Measurements of blood pressure via arm cuff and finger cuff
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 week post-op.
Baseline Laboratory Tests
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Measured: Baseline
1 week post-op Laboratory Tests
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Measured: 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
Measured: 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
Measured: 8 week post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20201 Nov 2025

First posted22 Oct 2020
Study start1 Nov 2020
Primary completion1 Nov 2025 (estimated)
Study completion1 Nov 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 72 participants (estimated)
Target duration: 2 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04598035
Sponsor's protocol ID: 00145752
Acronym: ESCAPE
Status last verified: Aug 2025
First submitted: 7 Oct 2020
Last updated: 7 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: IPD may be available upon reasonable request

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
ClinicalTrials.gov ID: NCT04598035
Acronym / sponsor ID: ESCAPE / 00145752
Conditions: Chronic Pain, Hypertension, Implanted Stimulation Electrodes
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 72 participants (estimated)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Study start: 1 Nov 2020 (actual)
Primary completion: 1 Nov 2025 (estimated)
Study completion: 1 Nov 2025 (estimated)
First posted: 22 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Months
Number of arms: 2

Arm	Type	Receives
Primary Group	–	Diagnostic Test: Diagnostic TestsPatients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device.
Control Group	–	Diagnostic Test: Diagnostic TestsPatients 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.

Who may qualify

Ages: 30 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diagnostic Tests1. Blood and Urine laboratory tests 2. ECG and blood pressure for cardiovascular measurements 3. Self-report questionnaires about pain	Diagnostic test	Control Group, Primary Group

Primary outcome

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 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 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 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.
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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Individual participant dataSharing planned: Undecided. IPD may be available upon reasonable request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seth W Holwerda, PhD principal investigator

University of Kansas Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Hypertension, run by University of Kansas Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Blood Pressure Measurement to 1 week post-op (time frame: Baseline and 1 week post-op). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.