NCT04676399

Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Hypertension
• Diuretics Drug Reactions
• SCS

Interventions

Type	Name	Description
DRUG	Hydrochlorothiazide 12.5mg	2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
DRUG	Placebo	2 pills/day (1 pill every morning and 1 pill every evening) for 14 days

Timeline

• Start date: 2022-02-08
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-12-21
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study