Status:
ACTIVE_NOT_RECRUITING
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Chronic Pain
Hypertension
Eligibility:
All Genders
40-79 years
Phase:
EARLY_PHASE1
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 pla...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04676399
Start Date
February 8 2022
End Date
December 1 2027
Last Update
September 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
Kansas City, Kansas, United States, 66160