Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration

Study Overview
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Brief Summary
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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
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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

Official Title
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Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Suture
* Device: Dermabond


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture Group<br>secure one of the 2 trial leads with suture only-randomized to left or right | Device: Suture<br>* secures SCS trial leads with a suture<br>|
| Experimental: Dermabond<br>secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right | Device: Suture<br>* secures SCS trial leads with a suture<br>Device: Dermabond<br>* secures SCS trial leads with dermabond<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead migration between groups | 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 | From Baseline through Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Lower satisfaction in patients that had lead migration versus patients that did not. Satisfaction will be valued on a 0-10 scale, with 0- not satisfied at all up to 10- greatest level of satisfaction | Baseline, Day 8 | 
| Affect of length of trial on migration | Determination to see if a longer trial predisposes SCS trial lead insertion site to a higher rate of migration within a 5-8 day period as determined by initial x-ray post procedure to end of SCS trial x-ray | Baseline, Day 8 | 
| Prone fluoroscopy | Difference in lead position on prone (face down) fluoroscopy when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray | Baseline, Day 8 | 
| Number of patients who received pain relief from the SCS trial | Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial. | Baseline, Day 8 | 
| Upright x-ray | Difference in lead position on upright (standing) x-ray when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray | Baseline, Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Stimulation (SCS), chronic pain, stimulator