Epidural spinal cord stimulation for managing blood pressure and low back pain
Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
This study is testing if epidural spinal cord stimulation can help people with chronic low back pain and high blood pressure feel better by lowering their blood pressure and relieving their pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05556902 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of epidural spinal cord stimulation (SCS) on arterial blood pressure in patients suffering from chronic low back pain and hypertension. It aims to determine if SCS can reduce blood pressure and whether higher baseline blood pressure predicts greater pain relief following the procedure. Additionally, the study will explore the electrophysiological responses elicited by different SCS waveforms using advanced techniques like electroencephalography and magnetoencephalography. Patients will be monitored before and after the SCS implant to assess changes in blood pressure and pain levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-89 with chronic pain lasting more than three months and comorbid hypertension.
Not a fit: Patients with a history of neurological diseases, stroke, or current cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with chronic pain and hypertension, potentially improving their quality of life.
How similar studies have performed: While the specific combination of SCS for blood pressure and pain management is novel, previous studies have shown promising results with SCS in pain relief.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female, age 18-89 2. Chronic pain for more than 3 months 3. Willing to visit a research lab 4. Willing to undergo a blood draw 5. Able to provide written informed consent Exclusion Criteria 1. History of neurological disease (e.g., dementias, Parkinson's) 2. History of stroke 3. Current diagnosis of cancer 4. Subject is unwilling or unable to comply with the protocol
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Marshall Holland, MD — The University of Alabama at Birmingham
- Study coordinator: Chris Gonzalez, MS
- Email: clgonzalez@uabmc.edu
- Phone: (205) 975-3732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.