Chronic PainEarly Phase 1PASSIONNCT04676399
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
A Early Phase 1 study testing Hydrochlorothiazide 12.5mg in people with Chronic Pain and Hypertension, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Chronic Pain, Hypertension, Diuretics Drug Reactions
- What is being tested?
- Hydrochlorothiazide 12.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Pain, Hypertension, Diuretics Drug Reactions, SCS
- Being tested
- Hydrochlorothiazide 12.5mg, Placebo
- Medical subject headings
- Chronic Pain, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrochlorothiazide 12.5mgDrug
Also called HCTZ
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
PlaceboDrug
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Hydrochlorothiazide Pill (12.5 mg twice a day) | Experimental | 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 Receives: Drug: Hydrochlorothiazide 12.5mg |
| Placebo | Placebo comparator | Has no active ingredients but is made to look like the study drug.
2 pills/day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure Measurement From Visit 1 to Visit 2
Measurements of blood pressure via arm cuff and finger cuff
Measured: 1 week
Change in Blood Pressure Measurement From Visit 2 to Visit 3
Measurements of blood pressure via arm cuff and finger cuff
Measured: 1 week
Change in Blood Pressure Measurement From Visit 3 to Visit 4
Measurements of blood pressure via arm cuff and finger cuff
Measured: 1 week
Change in Blood Pressure Measurement From Visit 4 to Visit 5
Measurements of blood pressure via arm cuff and finger cuff
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- IL-6 normal values was 6-31 pg/mL
- TNF-α 5 pg/mL,
Measured: Visit 1 (Day 1)
Visit 1 Lipid Panel Blood Work Results
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
Measured: 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
- 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)
Measured: Visit 1 (Day 1)
Visit 1 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers
Measured: 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
- 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)
Measured: 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
- 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)
Measured: 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
- 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)
Measured: 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
- 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)
Measured: Visit 5 (Day 28)
Visit 5 Lipid Panel Blood Work Results
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
Measured: Visit 5 (Day 28)
Visit 5 Stored Plasma Blood Work Results
Stored plasma for inflammatory markers Blood Test
Measured: 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
- IL-6 normal values was 6-31 pg/mL
- TNF-α 5 pg/mL,
Measured: Visit 5 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start8 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth W Holwerda, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676399
- Sponsor's protocol ID
- 00146604
- Acronym
- PASSION
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
- ClinicalTrials.gov ID
- NCT04676399
- Acronym / sponsor ID
- PASSION / 00146604
- Conditions
- Chronic Pain, Hypertension, Diuretics Drug Reactions, SCS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
| Arm | Type | Receives |
|---|---|---|
| Hydrochlorothiazide Pill (12.5 mg twice a day) | Experimental | Drug: Hydrochlorothiazide 12.5mgPlanned 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 |
| Placebo | Placebo comparator | Drug: PlaceboHas no active ingredients but is made to look like the study drug. 2 pills/day for 14 days. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide 12.5mgAlso: HCTZ2 pills/day (1 pill every morning and 1 pill every evening) for 14 days. | Drug | Hydrochlorothiazide Pill (12.5 mg twice a day) |
| Placebo2 pills/day (1 pill every morning and 1 pill every evening) for 14 days | Drug | Placebo |
Primary outcome
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
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
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
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
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.
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.
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.
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.
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 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 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 Stored Plasma Blood Work Results
Time frame: Visit 1 (Day 1)
Stored plasma for inflammatory markers
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 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 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 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 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 Stored Plasma Blood Work Results
Time frame: Visit 5 (Day 35)
Stored plasma for inflammatory markers Blood Test
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,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided. IPD may be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth W Holwerda, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrochlorothiazide 12.5mg in people with Chronic Pain and Hypertension, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure Measurement From Visit 1 to Visit 2 (time frame: 1 week). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.