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

Last updated: July 13, 2023
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

external securement of scs leads during the scs trial period

Clinical Study ID

NCT05956548
1994689
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Adults ages 18 and over without a failed spinal stimulation trial or implant will beaccepted into the study. Patients must have a diagnosis of chronic back pain and must bepatients of the identified anesthesiologists and have their procedures performed at AUHSpain clinic.

Exclusion

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/ secondaryhyperhidrosis (chronic over sweating).

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: external securement of scs leads during the scs trial period
Phase:
Study Start date:
July 15, 2023
Estimated Completion Date:
July 14, 2024

Connect with a study center

  • Augusta University Health System Pain Clinic

    Augusta, Georgia 30912
    United States

    Active - Recruiting

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