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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Group | Patients with chronic low back pain that candidates them for surgical implant of a SCS device, and received a permanent SCS device. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Tests | Diagnostic Test |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)
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| Name | Affiliation | Role |
|---|---|---|
| Seth W Holwerda, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Clinical and Translational Science Unit (CTSU) | Fairway | Kansas | 66205 | United States | ||
IPD may be available upon reasonable request
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples
| 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 |
| The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |