Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Diuretics Drug Reactions
- Hypertension
- SCS
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Mixed Model 2-way analysis of variance to asses pain and BP responses to the diuretic vs. placebo.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Randomization to either hydrochlorothiazide or placebo will occur via a 1:1 ratio determined by computer generated randomization and stratified by age and sex to balance the two groups.Primary Purpose: Other
Participation Requirements
- Age
- Between 40 years and 79 years
- Gender
- Both males and females
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 (4 weeks of diuretic) improve a SCS device among patients with chronic pain and hypertension compared with placebo. ...
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 (4 weeks of diuretic) improve a SCS device among patients with chronic pain and hypertension compared with placebo. 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.
Tracking Information
- NCT #
- NCT04676399
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Seth W Holwerda, PhD University of Kansas Medical Center
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