Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response

Study Overview
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Brief Summary
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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: 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.

Official Title
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Contrasting Lead Migration During Spinal Stimulation Trial Period Against Therapeutic Response - Evaluating Securement Methods During the Trial Period

Conditions
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Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period

Intervention / Treatment
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* Procedure: external securement of scs leads during the scs trial period


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: external 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |