Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure Measurement From Visit 2 to Visit 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization to either hydrochlorothiazide or placebo using a crossover study design will occur via a 1:1 ratio determined by computer generated randomization
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hydrochlorothiazide Pill (12.5 mg twice a day)
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
干预措施: Hydrochlorothiazide 12.5mg (Drug)
Placebo
Has no active ingredients but is made to look like the study drug.
2 pills/day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Blood Pressure Measurement From Visit 2 to Visit 3
时间窗: 1 week
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 3 to Visit 4
时间窗: 1 week
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 1 to Visit 2
时间窗: 1 week
Measurements of blood pressure via arm cuff and finger cuff
Change in Blood Pressure Measurement From Visit 4 to Visit 5
时间窗: 2 week
Measurements of blood pressure via arm cuff and finger cuff
Change from Visit 2 PainDETECT Questionnaire to Visit 3
时间窗: 1 week
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 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
时间窗: Visit 2 (Day 7)
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 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
时间窗: Visit 5 (Day 28)
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,
Change from Visit 1 PainDETECT Questionnaire to Visit 2
时间窗: 1 week
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
时间窗: 1 week
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
时间窗: Visit 1 (Day 1)
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 Comprehensive Metabolic Panel Blood Work Results
时间窗: Visit 1 (Day 1)
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
时间窗: Visit 1 (Day 1)
Stored plasma for inflammatory markers
Change from Visit 4 PainDETECT Questionnaire to Visit 5
时间窗: 2 week
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 Lipid Panel Blood Work Results
时间窗: Visit 1 (Day 1)
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 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
时间窗: Visit 3 (Day 14)
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
时间窗: Visit 4 (Day 21)
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
时间窗: Visit 5 (Day 28)
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
时间窗: Visit 5 (Day 28)
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
时间窗: Visit 5 (Day 35)
Stored plasma for inflammatory markers Blood Test
次要结局
未报告次要终点