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Device

Spinal Cord Stimulation for Lower Back Pain

N/A

Recruiting

Led By Marshall Holland, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic pain for more than 3 months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 (4-6 weeks post-op)

Awards & highlights

Study Summary

This trial will study whether Spinal Cord Stimulation (SCS) can help reduce blood pressure and pain in patients with chronic low back pain and hypertension.

Who is the study for?

This trial is for men and women aged 18-89 who have had chronic lower back pain for over three months, also experiencing high blood pressure. Participants must be willing to visit a research lab, undergo a blood draw, and provide written consent. It's not suitable for those with neurological diseases like dementia or Parkinson's, history of stroke, cancer diagnosis, or inability to follow the study protocol.Check my eligibility

What is being tested?

The study tests if Permanent Epidural Spinal Cord Stimulation (SCS) can reduce high blood pressure in patients with chronic low back pain. It also examines if higher initial blood pressure predicts pain relief after SCS and how different SCS waveforms affect spinal cord activity and brain responses measured by EEG and MEG.See study design

What are the potential side effects?

While specific side effects are not listed here, epidural spinal cord stimulation procedures may generally include discomfort at the implant site, infection risk from surgery or blood draws, potential nerve damage risks associated with any spine procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been experiencing chronic pain for over 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 (4-6 weeks post-op)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 (4-6 weeks post-op)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (4-6 weeks post-op) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arterial Blood Pressure Change

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Patients that proceed with permanent implantation of a spinal cord stimulator.

Group II: ControlActive Control1 Intervention

Patients who do not proceed with permanent implantation of a spinal cord stimulator.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,274 Total Patients Enrolled

Marshall Holland, MDPrincipal InvestigatorThe University of Alabama at Birmingham

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Permanent Epidural Spinal Cord Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05556902 — N/A

Lower Back Pain Research Study Groups: Control, Treatment

Lower Back Pain Clinical Trial 2023: Permanent Epidural Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT05556902 — N/A

Permanent Epidural Spinal Cord Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556902 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for potential participants to join this research?

"The clinical trial in question, which was initially posted on August 2nd 2022 and most recently updated on September 23rd 2022 is no longer looking for participants. Nevertheless, there are still 1107 open trials that require volunteers at this time."

Answered by AI

Does this trial accept geriatric patients?

"This study is looking for participants between the ages of 30 and 89. In contrast to this, 68 patients under 18 and 938 over 65 have been accepted into other medical trials."

Answered by AI

Are there any specific criteria for becoming an eligible participant of this clinical trial?

"The current study is seeking 80 male and female participants, aged between 30-89, with chronic low back pain exceeding 3 months. Qualifying individuals must consent to visiting a research lab for assessment, undergoing blood tests and signing the informed consent form."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Marshall Holland 2022. "Therapeutic Mechanisms of Epidural Spinal Cord Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05556902.

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