Telefitting spinal cord stimulation for chronic pain management
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
This study is testing different types of spinal cord stimulation to see which one helps people with chronic back pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05741788 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of different spinal cord stimulation patterns in patients scheduled for treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization process where they will experience various stimulation types (tonic, burst, and multistim) while being blinded to the specific type used. Over four months, participants will report their daily pain scores to determine which stimulation pattern provides the most significant pain relief. The study aims to improve the success rate of spinal cord stimulation by identifying the most effective stimulation settings for individual patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are scheduled to undergo spinal cord stimulation and have a baseline pain rating of 6 or higher.
Not a fit: Patients who are scheduled for permanent implantation without a trial or those with existing neurostimulators may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective pain management strategies for patients with chronic pain conditions.
How similar studies have performed: While spinal cord stimulation is a well-established treatment, this specific approach of optimizing stimulation patterns through a blinded evaluation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 22 years of age or older * Scheduled to undergo spinal cord stimulation * English speaker * Baseline pain rating (NRS/VAS) \>=6 Exclusion Criteria: * Scheduled for permanent implantation only without trial * Presence of pacemakers or other neurostimulators * Pregnant * Inability to read or use smart phone * Individuals who are unable to consent * Employees or students of PI * Prisoners
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David Darrow, MD — University of Minnesota
- Study coordinator: David Darrow, MD
- Email: darro015@umn.edu
- Phone: 612-624-6666
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.