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Spinal Cord Stimulation
Spinal Cord Stimulation for Chronic Pain
N/A
Recruiting
Led By David Darrow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
22 years of age or older
Baseline pain rating (NRS/VAS) >=6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial studies how different types of electrical stimulation can reduce chronic back and leg pain. Participants report daily pain scores to identify the best setting for them.
Who is the study for?
This trial is for English-speaking adults aged 22 or older with chronic back pain or radiculopathy, who are scheduled to undergo spinal cord stimulation and have a baseline pain rating of 6 or higher. It excludes those getting permanent implants without a trial, people with pacemakers/neurostimulators, pregnant individuals, those unable to consent, employees/students of the principal investigator (PI), prisoners, and anyone unable to read/use a smartphone.Check my eligibility
What is being tested?
The study tests different patterns of spinal cord stimulation (tonic, burst, multistim) in patients with chronic pain. Participants will be blinded to the type they receive and report daily pain scores over four months. The most effective setting for reducing pain will be identified using Thompson sampling and recommended for future use.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from spinal cord stimulation can include discomfort at the site of implantation, tingling sensations from the electrical impulses, bleeding/infection risk post-surgery and potential equipment malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Select...
My pain level is 6 or higher on a scale of 0-10.
Select...
I am scheduled for a spinal cord stimulation procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility
Secondary outcome measures
Acceptability of procedure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,730 Total Patients Enrolled
8 Trials studying Chronic Pain
2,916 Patients Enrolled for Chronic Pain
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a permanent implant without a trial period.I am 22 years old or older.My pain level is 6 or higher on a scale of 0-10.I am unable to give consent by myself.You cannot read or use a smartphone.I am scheduled for a spinal cord stimulation procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for patient participation in this clinical experiment?
"According to the resources available on clinicaltrials.gov, this study is not accepting new patients at present. Initially published in March of 2023 and last edited in February, there are 769 other active trials that may be suitable for those seeking participation opportunities."
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