Clinical trial NCT04598035: Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
Official title: Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Hypertension
Implanted Stimulation Electrodes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic low back pain (complex regional pain syndrome, failed back surgery syndrome)

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.

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:

1. 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.
2. 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.
3. Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.

Eligibility criteria: * 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

Primary outcomes:
measure: Change from Baseline Blood Pressure Measurement to 1 week post-op
timeFrame: Baseline and 1 week post-op
measure: Change from Baseline Blood Pressure Measurement to 4 week post-op
timeFrame: Baseline and 4 week post-op
measure: Change from Baseline Blood Pressure Measurement to 8 week post-op
timeFrame: Baseline and 8 week post-op
measure: Change from Baseline PainDETECT Questionnaire to 1 week post-op
timeFrame: Baseline and 1 week post-op.
measure: Change from Baseline PainDETECT Questionnaire to 4 week post-op
timeFrame: Baseline and 4 week post-op.
measure: Change from Baseline PainDETECT Questionnaire to 8 week post-op
timeFrame: Baseline and 8 week post-op.
measure: Baseline Laboratory Tests
timeFrame: Baseline
measure: 1 week post-op Laboratory Tests
timeFrame: 1 week post-op
measure: 4 week post-op Laboratory Tests
timeFrame: 4 week post-op
measure: 8 week post-op Laboratory Tests
timeFrame: 8 week post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Fairway
country: United States
facility: University of Kansas Clinical and Translational Science Unit (CTSU)
state: Kansas
city: Kansas City
country: United States
facility: The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Seth W Holwerda, PhD
role: PRINCIPAL_INVESTIGATOR
References: