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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| external securement of scs leads during the scs trial period | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Response | % of pain relief achieved by the participant during the SCS trial period | SCS trial periods are 3-6 days at our facilty. |
| Lead position changes (migration) | final location of the SCS leads at the end of the scs trial period, as seen on imaging | the last day of the trial period which could be day 3 up to day 6, depending on length |
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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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie C Jones, Grad Student | Contact | 706-721-0211 | sjones23@augusta.edu | |
| Jeane Silva, PhD | Contact | 706-721-0211 | jsilva@augusta.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeane Silva, PhD | Augusta University | Study Chair |
| Stephanie C Jones, Grad Student | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University Health System Pain Clinic | Recruiting | Augusta | Georgia | 30912 | United States |
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