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Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676399
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Hypertension Diuretics Drug Reactions SCS Drug: Hydrochlorothiazide 12.5mg Drug: Placebo Early Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
Masking: Triple (Participant, Care Provider, Investigator)
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
Primary Purpose: Other
Official Title: Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydrochlorothiazide Pill (12.5 mg twice a day)

Planned use in this study

  1. Condition/disease indication(s): Hypertension
  2. Subject population: Chronic pain
  3. Dose(s): 12.5 mg twice per day for 14 days.
  4. Administration: Oral
  5. Dosing regimen: 12.5 mg twice per day
 Drug: Hydrochlorothiazide 12.5mg
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
Other Name: HCTZ
Placebo Comparator: Placebo

Has no active ingredients but is made to look like the study drug.

2 pills/day for 14 days.

 Drug: Placebo
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Change in Blood Pressure Measurement From Visit 1 to Visit 2 [ Time Frame: 1 week ]
    Measurements of blood pressure via arm cuff and finger cuff

  2. Change in Blood Pressure Measurement From Visit 2 to Visit 3 [ Time Frame: 1 week ]
    Measurements of blood pressure via arm cuff and finger cuff

  3. Change in Blood Pressure Measurement From Visit 3 to Visit 4 [ Time Frame: 1 week ]
    Measurements of blood pressure via arm cuff and finger cuff

  4. Change in Blood Pressure Measurement From Visit 4 to Visit 5 [ Time Frame: 2 week ]
    Measurements of blood pressure via arm cuff and finger cuff

  5. Change from Visit 1 PainDETECT Questionnaire to Visit 2 [ Time Frame: 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.


  6. Change from Visit 2 PainDETECT Questionnaire to Visit 3 [ Time Frame: 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.


  7. Change from Visit 3 PainDETECT Questionnaire to Visit 4 [ Time Frame: 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.


  8. Change from Visit 4 PainDETECT Questionnaire to Visit 5 [ Time Frame: 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.


  9. Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work [ Time Frame: 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,

  10. Visit 1 Lipid Panel Blood Work Results [ Time Frame: 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

  11. Visit 1 Comprehensive Metabolic Panel Blood Work Results [ Time Frame: 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)

  12. Visit 1 Stored Plasma Blood Work Results [ Time Frame: Visit 1 (Day 1) ]
    Stored plasma for inflammatory markers

  13. Visit 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results [ Time Frame: 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)

  14. Visit 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results [ Time Frame: 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)

  15. Visit 4 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results [ Time Frame: 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)

  16. Visit 5 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results [ Time Frame: 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)

  17. Visit 5 Lipid Panel Blood Work Results [ Time Frame: 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

  18. Visit 5 Stored Plasma Blood Work Results [ Time Frame: Visit 5 (Day 35) ]
    Stored plasma for inflammatory markers Blood Test

  19. Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work [ Time Frame: 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,


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female, age 40-79
  2. Chronic low back pain
  3. Permanent spinal cord stimulator implant for chronic pain
  4. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk ≥10%
  5. Stage 2 hypertension (BP ≥ 140/90 mmHg)
  6. Willing to visit research lab (Fairway CTSU)
  7. Willing to undergo a blood draw
  8. Able to provide written informed consent

Exclusion Criteria:

  1. Any history of abnormal responses (allergy) to thiazide-type drugs
  2. Currently taking any antihypertensive medication
  3. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk <10%
  4. BP ≥160/100 (these patients should be promptly treated with 2 medications)
  5. Secondary hypertension (e.g., aldosteronism, renal artery stenosis)
  6. Symptomatic hypotension (weakness or syncope upon standing)
  7. Renal failure
  8. Diabetes requiring insulin or glucose-lowering drugs
  9. History of neurological disease (e.g., dementias, Parkinson's)
  10. History of stroke
  11. Current diagnosis of cancer
  12. Women who are pregnant or planning to become pregnant
  13. Any active infection
  14. Subject is unwilling or unable to comply with the protocol
  15. If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676399


Contacts
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Contact: Seth W Holwerda, PhD 913-588-5000 sholwerda@kumc.edu

Locations
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United States, Kansas
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Seth W Holwerda, PhD University of Kansas Medical Center
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04676399    
Other Study ID Numbers: 00146604
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be available upon reasonable request

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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
Additional relevant MeSH terms:
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Chronic Pain
Drug-Related Side Effects and Adverse Reactions
Pain
Neurologic Manifestations
Chemically-Induced Disorders
Hydrochlorothiazide
Antihypertensive Agents
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action