Clinical trial NCT04676399: Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Official title: Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Pain
Hypertension
Diuretics Drug Reactions
SCS
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Blood Pressure Measurement From Visit 1 to Visit 2
timeFrame: 1 week
measure: Change in Blood Pressure Measurement From Visit 2 to Visit 3
timeFrame: 1 week
measure: Change in Blood Pressure Measurement From Visit 3 to Visit 4
timeFrame: 1 week
measure: Change in Blood Pressure Measurement From Visit 4 to Visit 5
timeFrame: 2 week
measure: Change from Visit 1 PainDETECT Questionnaire to Visit 2
timeFrame: 1 week
measure: Change from Visit 2 PainDETECT Questionnaire to Visit 3
timeFrame: 1 week
measure: Change from Visit 3 PainDETECT Questionnaire to Visit 4
timeFrame: 1 week
measure: Change from Visit 4 PainDETECT Questionnaire to Visit 5
timeFrame: 2 week
measure: Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
timeFrame: Visit 1 (Day 1)
measure: Visit 1 Lipid Panel Blood Work Results
timeFrame: Visit 1 (Day 1)
measure: Visit 1 Comprehensive Metabolic Panel Blood Work Results
timeFrame: Visit 1 (Day 1)
measure: Visit 1 Stored Plasma Blood Work Results
timeFrame: Visit 1 (Day 1)
measure: Visit 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
timeFrame: Visit 2 (Day 7)
measure: Visit 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
timeFrame: Visit 3 (Day 14)
measure: Visit 4 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
timeFrame: Visit 4 (Day 21)
measure: Visit 5 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results
timeFrame: Visit 5 (Day 28)
measure: Visit 5 Lipid Panel Blood Work Results
timeFrame: Visit 5 (Day 28)
measure: Visit 5 Stored Plasma Blood Work Results
timeFrame: Visit 5 (Day 35)
measure: Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work
timeFrame: Visit 5 (Day 28)
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Seth W Holwerda, PhD
role: PRINCIPAL_INVESTIGATOR
References: