Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period
Conditions
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: * 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? * 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.
Interventions
PROCEDUREexternal securement of scs leads during the scs trial period
two groups- one group will have an anchor device used alone to secure the leads, the second group will have an anchor device with a suture to secure the leads
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactStephanie C Jones, Grad Student
Backup ContactJeane Silva, PhD
Outcome results
None listed