NCT04676399Active, not recruitingEarly phase 1
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 19 Nov 2020
- Start date
- Feb 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- High blood pressure
- NCT number
- NCT04676399
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 36
- From Feb 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking any antihypertensive medication
- BP ≥160/100 (these patients should be promptly treated with 2 medications)
- If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study
Other illness
- Any history of abnormal responses (allergy) to thiazide-type drugs
- Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk \<10%
- Secondary hypertension (e.g., aldosteronism, renal artery stenosis)
- Renal failure
- History of neurological disease (e.g., dementias, Parkinson's)
- History of stroke
- Current diagnosis of cancer
- Any active infection
Lab values
- Diabetes requiring insulin or glucose-lowering drugs
Other
- Symptomatic hypotension (weakness or syncope upon standing)
- Women who are pregnant or planning to become pregnant
- Subject is unwilling or unable to comply with the protocol
Who the study is looking for
- 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
Age in the registry: 40 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.