An observational study in Chronic Pain, Hypertension and Implanted Stimulation Electrodes, sponsored by University of Kansas Medical Center. Active, not recruiting at 2 sites in United States. Open to participants aged 30 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by University of Kansas Medical Center · Observational
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.
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:
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 72 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)
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
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
1. Blood and Urine laboratory tests 2. ECG and blood pressure for cardiovascular measurements 3. Self-report questionnaires about pain
Change from Baseline Blood Pressure Measurement to 1 week post-op
Measurements of blood pressure via arm cuff and finger cuff
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 week post-op.
Baseline Laboratory Tests
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Time frame: Baseline
1 week post-op Laboratory Tests
Serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), TNF-alpha, 8-Isoprostane
Time frame: 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
Time frame: 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
Time frame: 8 week post-op
Plan to share: Undecided — IPD may be available upon reasonable request
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center