Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.
The main question[s] it aims to answer are:
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Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
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How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.
Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Therapeutic Response [SCS trial periods are 3-6 days at our facilty.]
% of pain relief achieved by the participant during the SCS trial period
- Lead position changes (migration) [the last day of the trial period which could be day 3 up to day 6, depending on length]
final location of the SCS leads at the end of the scs trial period, as seen on imaging
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Augusta University Health System Pain Clinic | Augusta | Georgia | United States | 30912 |
Sponsors and Collaborators
- Augusta University
Investigators
- Study Chair: Jeane Silva, PhD, Augusta University
- Principal Investigator: Stephanie C Jones, Grad Student, Augusta University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1994689