Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
NCT ID: NCT04676399
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
36 participants
INTERVENTIONAL
2022-02-08
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Hydrochlorothiazide Pill (12.5 mg twice a day)
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
Hydrochlorothiazide 12.5mg
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
Placebo
Has no active ingredients but is made to look like the study drug.
2 pills/day for 14 days.
Placebo
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days
Interventions
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Hydrochlorothiazide 12.5mg
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days.
Placebo
2 pills/day (1 pill every morning and 1 pill every evening) for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
79 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Seth W Holwerda, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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00146604
Identifier Type: -
Identifier Source: org_study_id
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