Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study (PASSION study) is to monitor symptoms of chronic pain before and after 4 weeks of a standard drug commonly used to treat elevated blood pressure so that we may better understand how blood pressure affects your level of pain. This study is not testing an experimental drug.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Hydrochlorothiazide

Criteria

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