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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrochlorothiazide Pill (12.5 mg twice a day) | Experimental | Planned use in this study
|
|
| Placebo | Placebo Comparator | Has no active ingredients but is made to look like the study drug. 2 pills/day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide 12.5mg | Drug | 2 pills/day (1 pill every morning and 1 pill every evening) for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure Measurement From Visit 1 to Visit 2 | Measurements of blood pressure via arm cuff and finger cuff | 1 week |
| Change in Blood Pressure Measurement From Visit 2 to Visit 3 | Measurements of blood pressure via arm cuff and finger cuff | 1 week |
| Change in Blood Pressure Measurement From Visit 3 to Visit 4 | Measurements of blood pressure via arm cuff and finger cuff | 1 week |
| Change in Blood Pressure Measurement From Visit 4 to Visit 5 | Measurements of blood pressure via arm cuff and finger cuff | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center | Kansas City | Kansas | 66160 | 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 |
|---|---|
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
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Randomization to either hydrochlorothiazide or placebo using a crossover study design will occur via a 1:1 ratio determined by computer generated randomization
| Placebo | Drug | 2 pills/day (1 pill every morning and 1 pill every evening) for 14 days |
|
| 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. | 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. | 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
| Visit 1 (Day 1) |
| Visit 1 Lipid Panel Blood Work Results | Lipid panel Blood Test: mg/dL,
| 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
| Visit 1 (Day 1) |
| Visit 1 Stored Plasma Blood Work Results | Stored plasma for inflammatory markers | 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
| 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
| 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
| 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
| Visit 5 (Day 28) |
| Visit 5 Lipid Panel Blood Work Results | Lipid panel Blood Test: mg/dL,
| Visit 5 (Day 28) |
| Visit 5 Stored Plasma Blood Work Results | Stored plasma for inflammatory markers Blood Test | 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
| Visit 5 (Day 28) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |