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. 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
DEVICESuture and Dermabond
secures SCS trial leads with dermabond and suture
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 Distance of Trial Leads | From Baseline through Day 8 | Migration distance 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. The survey asked general questions about participant satisfaction with the spinal cord stimulator (SCS) trial experience (overall satisfaction with experience), not about participant satisfaction with the Dermabond or suture fixation interventions separately. |
| Rate of Infection | Day 8 | percent of participants with a higher rate of infection |
| 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
Contacts
PRINCIPAL_INVESTIGATORCarlyle Hamsher, MD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
None listed