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Active, Not Recruiting

NCT Number: NCT04676399

Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Cardiovascular Diseases Diuretics Drug Reactions Hypertension Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms SCS Signs and Symptoms Vascular Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrochlorothiazide 12.5mg

Drug

2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.

Other names: HCTZ

Placebo

Drug

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

Primary outcomes

  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,

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: PASSION

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 21, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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