Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

Hypertension Clinical Trial

— PASSION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676399
• Other study ID #: 00146604
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: University of Kansas Medical Center
• Contact: Seth W Holwerda, PhD
• Phone: 913-588-5000
• Email: sholwerda[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study is not testing an experimental drug.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Diuretics Drug Reactions
• Drug-Related Side Effects and Adverse Reactions
• Hypertension
• SCS

Intervention

Drug:
• Hydrochlorothiazide 12.5mg
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
• Placebo
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days

Locations

Country	Name	City	State
United States	The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure Measurement From Visit 1 to Visit 2	Measurements of blood pressure via arm cuff and finger cuff	1 week
Primary	Change in Blood Pressure Measurement From Visit 2 to Visit 3	Measurements of blood pressure via arm cuff and finger cuff	1 week
Primary	Change in Blood Pressure Measurement From Visit 3 to Visit 4	Measurements of blood pressure via arm cuff and finger cuff	1 week
Primary	Change in Blood Pressure Measurement From Visit 4 to Visit 5	Measurements of blood pressure via arm cuff and finger cuff	2 week
Primary	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
Primary	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.	1 week
Primary	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
Primary	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
Primary	Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-a) 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-a) and interlukin-6 (IL6) Blood Test: pg/mL; IL-6 normal values was 6-31 pg/mL; TNF-a 5 pg/mL,	Visit 1 (Day 1)
Primary	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	Visit 1 (Day 1)
Primary	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)	Visit 1 (Day 1)
Primary	Visit 1 Stored Plasma Blood Work Results	Stored plasma for inflammatory markers	Visit 1 (Day 1)
Primary	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)	Visit 2 (Day 7)
Primary	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)	Visit 3 (Day 14)
Primary	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)	Visit 4 (Day 21)
Primary	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)	Visit 5 (Day 28)
Primary	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	Visit 5 (Day 28)
Primary	Visit 5 Stored Plasma Blood Work Results	Stored plasma for inflammatory markers Blood Test	Visit 5 (Day 35)
Primary	Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-a) 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-a) and interlukin-6 (IL6) Blood Test: pg/mL; IL-6 normal values was 6-31 pg/mL; TNF-a 5 pg/mL,	Visit 5 (Day 28)