Comparing lead migration and response in spinal cord stimulation
Contrasting Lead Migration During Spinal Stimulation Trial Period Against Therapeutic Response - Evaluating Securement Methods During the Trial Period
This study is testing how different ways of securing spinal cord stimulation leads affect their movement in patients and if factors like activity levels and weather play a role.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT05956548 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the distance and rate of lead migration in patients undergoing spinal cord stimulation during the trial period. Participants will be divided into two groups based on the method of securing the leads: one using an anchor device and the other using an anchor device with suture. The study will also assess how participant activity levels and environmental factors like temperature and humidity affect lead migration. Participants will complete an activity survey and undergo imaging to document lead position before lead removal.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with chronic back pain who have not previously failed a spinal stimulation trial.
Not a fit: Patients with a history of local anesthetic allergy, current skin infections at the procedure site, or chronic over sweating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness and safety of spinal cord stimulation therapies for chronic back pain.
How similar studies have performed: While there is limited information on similar studies, the approach of comparing lead migration methods in spinal cord stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic. Exclusion Criteria: Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).
Where this trial is running
Augusta, Georgia
- Augusta University Health System Pain Clinic — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie C Jones, Grad Student — Augusta University
- Study coordinator: Stephanie C Jones, Grad Student
- Email: sjones23@augusta.edu
- Phone: 706-721-0211
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.