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

September 3, 2025 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 week
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
1 week
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
1 week
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
2 week
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.
1 week
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.
1 week
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.
1 week
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.
2 week
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,
Visit 1 (Day 1)
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
Visit 1 (Day 1)
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)
Visit 1 (Day 1)
Visit 1 Stored Plasma Blood Work Results
Time Frame: Visit 1 (Day 1)
Stored plasma for inflammatory markers
Visit 1 (Day 1)
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)
Visit 2 (Day 7)
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)
Visit 3 (Day 14)
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)
Visit 4 (Day 21)
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)
Visit 5 (Day 28)
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
Visit 5 (Day 28)
Visit 5 Stored Plasma Blood Work Results
Time Frame: Visit 5 (Day 35)
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
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,
Visit 5 (Day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seth W Holwerda, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00146604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD may be available upon reasonable request

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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