Recruiting

Spinal Cord Stimulation

Sponsor:

Augusta University

Code:

NCT05956548

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

external securement of scs leads during the scs trial period

Study Details

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.

Conditions

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

Study ID

NCT05956548

Start date

Jul 15, 2023

Status verified date

Jul, 2023

Completion date

Jul 14, 2024

Anticipated

Primary completion date

May 14, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Therapeutic Response [ Time Frame: SCS trial periods are 3-6 days at our facilty. ]
  • Lead position changes (migration) [ Time Frame: the last day of the trial period which could be day 3 up to day 6, depending on length ]

Central Contacts and Locations

Central contacts

Stephanie C Jones, Grad Student

706-721-0211sjones23@augusta.edu

Jeane Silva, PhD

706-721-0211jsilva@augusta.edu

Locations

Augusta University Health System Pain Clinic

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Anterpreet Dua, MD

706-721-8623adua@augusta.edu

Zhuo Sun, MD

706-721-8623zsun@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 21, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-07-21.