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.
The goal of the PASSION study is to determine the extent to which reductions in blood pressure improve pain management via SCS 1. 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. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
36
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
Kansas City, Kansas, United States
Change in Blood Pressure Measurement From Visit 1 to Visit 2
Measurements of blood pressure via arm cuff and finger cuff
Time frame: 1 week
Change in Blood Pressure Measurement From Visit 2 to Visit 3
Measurements of blood pressure via arm cuff and finger cuff
Time frame: 1 week
Change in Blood Pressure Measurement From Visit 3 to Visit 4
Measurements of blood pressure via arm cuff and finger cuff
Time frame: 1 week
Change in Blood Pressure Measurement From Visit 4 to Visit 5
Measurements of blood pressure via arm cuff and finger cuff
Time frame: 2 week
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.
Time frame: 1 week
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 week
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.
Time frame: 1 week
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.
Time frame: 2 week
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,
Time frame: Visit 1 (Day 1)
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
Time frame: Visit 1 (Day 1)
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)
Time frame: Visit 1 (Day 1)
Visit 1 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers
Time frame: Visit 1 (Day 1)
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)
Time frame: Visit 2 (Day 7)
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)
Time frame: Visit 3 (Day 14)
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)
Time frame: Visit 4 (Day 21)
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)
Time frame: Visit 5 (Day 28)
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
Time frame: Visit 5 (Day 28)
Visit 5 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers Blood Test
Time frame: Visit 5 (Day 35)
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,
Time frame: Visit 5 (Day 28)