Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION)
Primary Purpose
Chronic Pain, Hypertension, Diuretics Drug Reactions
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydrochlorothiazide 12.5mg
Placebo
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Male or Female, age 40-79
- Chronic low back pain
- Permanent spinal cord stimulator implant for chronic pain
- Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk ≥10%
- Stage 2 hypertension (BP ≥ 140/90 mmHg)
- Willing to visit research lab (Fairway CTSU)
- Willing to undergo a blood draw
- Able to provide written informed consent
Exclusion Criteria:
- Any history of abnormal responses (allergy) to thiazide-type drugs
- Currently taking any antihypertensive medication
- Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk <10%
- BP ≥160/100 (these patients should be promptly treated with 2 medications)
- Secondary hypertension (e.g., aldosteronism, renal artery stenosis)
- Symptomatic hypotension (weakness or syncope upon standing)
- Renal failure
- Diabetes requiring insulin or glucose-lowering drugs
- History of neurological disease (e.g., dementias, Parkinson's)
- History of stroke
- Current diagnosis of cancer
- Women who are pregnant or planning to become pregnant
- Any active infection
- Subject is unwilling or unable to comply with the protocol
- If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study
Sites / Locations
- The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrochlorothiazide Pill (12.5 mg twice a day)
Placebo
Arm Description
Planned use in this study Condition/disease indication(s): Hypertension Subject population: Chronic pain Dose(s): 12.5 mg twice per day for 14 days. Administration: Oral Dosing regimen: 12.5 mg twice per day
Has no active ingredients but is made to look like the study drug. 2 pills/day for 14 days.
Outcomes
Primary Outcome Measures
Change in Blood Pressure Measurement From Visit 1 to Visit 2
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 2 to Visit 3
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 3 to Visit 4
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 4 to Visit 5
Measurements of blood pressure via arm cuff and finger cuff
Change from Visit 1 PainDETECT Questionnaire to Visit 2
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 Visit 2 PainDETECT Questionnaire to Visit 3
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 Visit 3 PainDETECT Questionnaire to Visit 4
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 Visit 4 PainDETECT Questionnaire to Visit 5
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.
Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
Catecholamines( Norepinephrine) Blood Test: pg/mL
• normal range for norepinephrine is 70 to 1700 pg/mL
Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL
IL-6 normal values was 6-31 pg/mL
TNF-α 5 pg/mL,
Visit 1 Lipid Panel Blood Work Results
Lipid panel Blood Test: mg/dL,
Total Cholesterol Less than 170mg/dL
Non-HDL Less than 120mg/dL
LDL Less than 100mg/dL
HDL More than 45mg/dL
Visit 1 Comprehensive Metabolic Panel Blood Work Results
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Visit 1 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers
Visit 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Visit 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Visit 4 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Visit 5 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Visit 5 Lipid Panel Blood Work Results
Lipid panel Blood Test: mg/dL,
Total Cholesterol Less than 170mg/dL
Non-HDL Less than 120mg/dL
LDL Less than 100mg/dL
HDL More than 45mg/dL
Visit 5 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers Blood Test
Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
Catecholamines( Norepinephrine) Blood Test: pg/mL
• normal range for norepinephrine is 70 to 1700 pg/mL
Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL
IL-6 normal values was 6-31 pg/mL
TNF-α 5 pg/mL,
Secondary Outcome Measures
Full Information
NCT ID
NCT04676399
First Posted
November 19, 2020
Last Updated
February 8, 2022
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04676399
Brief Title
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Acronym
PASSION
Official Title
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study (PASSION study) is to monitor symptoms of chronic pain before and after 2 weeks of a standard drug commonly used to treat elevated blood pressure compared with 2 weeks of placebo (crossover design) so that we may better understand how blood pressure affects your level of pain. This study is not testing an experimental drug.
Detailed Description
The goal of the PASSION study is to determine the extent to which reductions in blood pressure improve pain management via SCS
Examine the extent to which reductions in blood pressure (2 weeks of diuretic and 2 weeks of placebo) improve pain management among patients with chronic pain and hypertension compared.
Examine the extent to which arterial baroreflex function, which is critical to blood pressure regulation, is impaired in patients with chronic pain and hypertension and is correlated with chronic pain symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Hypertension, Diuretics Drug Reactions, SCS
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomization to either hydrochlorothiazide or placebo using a crossover study design will occur via a 1:1 ratio determined by computer generated randomization
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrochlorothiazide Pill (12.5 mg twice a day)
Arm Type
Experimental
Arm Description
Planned use in this study
Condition/disease indication(s): Hypertension
Subject population: Chronic pain
Dose(s): 12.5 mg twice per day for 14 days.
Administration: Oral
Dosing regimen: 12.5 mg twice per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Has no active ingredients but is made to look like the study drug.
2 pills/day for 14 days.
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide 12.5mg
Other Intervention Name(s)
HCTZ
Intervention Description
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days
Primary Outcome Measure Information:
Title
Change in Blood Pressure Measurement From Visit 1 to Visit 2
Description
Measurements of blood pressure via arm cuff and finger cuff
Time Frame
1 week
Title
Change in Blood Pressure Measurement From Visit 2 to Visit 3
Description
Measurements of blood pressure via arm cuff and finger cuff
Time Frame
1 week
Title
Change in Blood Pressure Measurement From Visit 3 to Visit 4
Description
Measurements of blood pressure via arm cuff and finger cuff
Time Frame
1 week
Title
Change in Blood Pressure Measurement From Visit 4 to Visit 5
Description
Measurements of blood pressure via arm cuff and finger cuff
Time Frame
2 week
Title
Change from Visit 1 PainDETECT Questionnaire to Visit 2
Description
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
1 week
Title
Change from Visit 2 PainDETECT Questionnaire to Visit 3
Description
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
1 week
Title
Change from Visit 3 PainDETECT Questionnaire to Visit 4
Description
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
1 week
Title
Change from Visit 4 PainDETECT Questionnaire to Visit 5
Description
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
2 week
Title
Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
Description
Catecholamines( Norepinephrine) Blood Test: pg/mL
• normal range for norepinephrine is 70 to 1700 pg/mL
Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL
IL-6 normal values was 6-31 pg/mL
TNF-α 5 pg/mL,
Time Frame
Visit 1 (Day 1)
Title
Visit 1 Lipid Panel Blood Work Results
Description
Lipid panel Blood Test: mg/dL,
Total Cholesterol Less than 170mg/dL
Non-HDL Less than 120mg/dL
LDL Less than 100mg/dL
HDL More than 45mg/dL
Time Frame
Visit 1 (Day 1)
Title
Visit 1 Comprehensive Metabolic Panel Blood Work Results
Description
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Time Frame
Visit 1 (Day 1)
Title
Visit 1 Stored Plasma Blood Work Results
Description
Stored plasma for inflammatory markers
Time Frame
Visit 1 (Day 1)
Title
Visit 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Description
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Time Frame
Visit 2 (Day 7)
Title
Visit 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Description
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Time Frame
Visit 3 (Day 14)
Title
Visit 4 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Description
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Time Frame
Visit 4 (Day 21)
Title
Visit 5 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
Description
Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L
Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L)
Alkaline phosphatase: 20 to 130 U/L
ALT (alanine aminotransferase): 4 to 36 U/L
AST (aspartate aminotransferase): 8 to 33 U/L
BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L)
Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L)
Chloride: 96 to 106 mEq/L (96 to 106 mmol/L)
CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L)
Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L)
Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L)
Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L)
Sodium: 135 to 145 mEq/L (135 to 145 mmol/L)
Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L)
Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L)
Time Frame
Visit 5 (Day 28)
Title
Visit 5 Lipid Panel Blood Work Results
Description
Lipid panel Blood Test: mg/dL,
Total Cholesterol Less than 170mg/dL
Non-HDL Less than 120mg/dL
LDL Less than 100mg/dL
HDL More than 45mg/dL
Time Frame
Visit 5 (Day 28)
Title
Visit 5 Stored Plasma Blood Work Results
Description
Stored plasma for inflammatory markers Blood Test
Time Frame
Visit 5 (Day 35)
Title
Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
Description
Catecholamines( Norepinephrine) Blood Test: pg/mL
• normal range for norepinephrine is 70 to 1700 pg/mL
Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL
IL-6 normal values was 6-31 pg/mL
TNF-α 5 pg/mL,
Time Frame
Visit 5 (Day 28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female, age 40-79
Chronic low back pain
Permanent spinal cord stimulator implant for chronic pain
Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk ≥10%
Stage 2 hypertension (BP ≥ 140/90 mmHg)
Willing to visit research lab (Fairway CTSU)
Willing to undergo a blood draw
Able to provide written informed consent
Exclusion Criteria:
Any history of abnormal responses (allergy) to thiazide-type drugs
Currently taking any antihypertensive medication
Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk <10%
BP ≥160/100 (these patients should be promptly treated with 2 medications)
Secondary hypertension (e.g., aldosteronism, renal artery stenosis)
Symptomatic hypotension (weakness or syncope upon standing)
Renal failure
Diabetes requiring insulin or glucose-lowering drugs
History of neurological disease (e.g., dementias, Parkinson's)
History of stroke
Current diagnosis of cancer
Women who are pregnant or planning to become pregnant
Any active infection
Subject is unwilling or unable to comply with the protocol
If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seth W Holwerda, PhD
Phone
913-588-5000
Email
sholwerda@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth W Holwerda, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be available upon reasonable request
Learn more about this trial
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
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