Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
Active, not recruitingEarly phase 1NCT04676399
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION Study)
- Conditions
- Chronic Pain
- Hypertension
- Diuretics Drug Reactions
- SCS
- Interventions
- Drug: Hydrochlorothiazide 12.5mg
- Drug: Placebo
- Sponsor
- University of Kansas Medical Center
- Start date
- 2022-02-08
- Primary completion
- 2026-12
- Sex
- All
- Age range
- from 40 Years to 79 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04676399