Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation (SCS), chronic pain, stimulator
Brief summary
During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
Detailed description
Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain.1 Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length . During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
Interventions
DEVICESuture
secures SCS trial leads with a suture
DEVICEDermabond
secures SCS trial leads with dermabond
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age greater than 18 * having a spinal cord stimulator trial lead placement done * lead placement to be done in the thoracic spine area
Exclusion criteria
* dermabond allergy * inability to place 2 leads in subject * lead placement not in thoracic spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration rate of trial leads | From Baseline through Day 8 | Migration rate of trial leads anchored with Dermabond and suture versus suture alone will be measured by change in trial lead position as measured in millimeters when comparing initial x-ray after placement versus x-ray taken at lead removal 5-8 days after placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | Day 8 | Patient satisfaction score will be valued on a 0-10 scale, with 0-not satisfied at all up to 10-greatest level of satisfaction |
| Rate of Infection | Day 8 | determine if a longer trial predisposes spinal cord stimulation trial lead insertion site to a higher rate of infection |
| Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray | Day 8 | Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray |
| Number of Patients with Pain Relief | Day 8 | Number of patients who received pain relief from the spinal cord stimulation trial. Number of responders to the prognostic lead placements defined as \>50% pain relief over the length of the trial. |
Countries
United States
Outcome results
None listed