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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period
Intervention / Treatment

-

Contacts and Locations

Augusta

Augusta University Health System Pain Clinic, Augusta, Georgia, United States, 30912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Augusta University,

    Jeane Silva, PhD, STUDY_CHAIR, Augusta University

    Stephanie C Jones, Grad Student, PRINCIPAL_INVESTIGATOR, Augusta University

    Study Record Dates

    2024-07-14