Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction (PASSION)

University of Kansas

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Hypertension; Diuretics Drug Reactions; Chronic Pain; SCS

Treatments: Drug: Hydrochlorothiazide 12.5mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04676399

00146604

Details and patient eligibility

About

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.

Full 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 diuretic and 2 weeks of placebo) improve pain management among patients with chronic pain and hypertension compared.
2. 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Hydrochlorothiazide Pill (12.5 mg twice a day)

Experimental group

Description:

Planned use in this study 1. Condition/disease indication(s): Hypertension 2. Subject population: Chronic pain 3. Dose(s): 12.5 mg twice per day for 14 days. 4. Administration: Oral 5. Dosing regimen: 12.5 mg twice per day

Treatment:

Drug: Hydrochlorothiazide 12.5mg

Placebo

Placebo Comparator group

Description:

Has no active ingredients but is made to look like the study drug. 2 pills/day for 14 days.

Treatment:

Drug: Placebo