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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture Group | Active Comparator | secure one of the 2 trial leads with suture only-randomized to left or right |
|
| Dermabond and Suture Group | Experimental | secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture | Device | secures SCS trial leads with a suture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration Distance of Trial Leads | 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 | From Baseline through Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray | Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray | Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlyle Hamsher, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42398024 | Derived | Hurley RW, Patel JS, Bintrim DJ, Oliver JB, Miranda A, Rahmah T, Hamsher CP. Dermabond Versus Suture Fixation for Spinal Cord Stimulator Trial Lead Anchoring: A Randomized Within-Patient Controlled Trial. Pain Med. 2026 Jul 3:pnag083. doi: 10.1093/pm/pnag083. Online ahead of print. |
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analysis will include all participant data via publication
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right. This study will be a controlled trial of the two standard of care methods of securing SCS leads in which the trial leads (left and right) will be secured with one lead being secured with a suture only while the second lead will be secured after placement with both a suture in addition to Dermabond. The patient will serve as their own control. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Migration Distance of Trial Leads | 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 | Posted | Mean | Standard Deviation | mm | From Baseline through Day 8 |
|
Through day 8
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlyle Hamsher, MD | Atrium Health Wake Forest Baptist | 336-716-4498 | Carlyle.Hamsher@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2025 | Feb 25, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2025 | Jul 25, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Suture and Dermabond | Device | secures SCS trial leads with dermabond and suture |
|
| Day 8 |
| Rate of Infection | percent of participants with a higher rate of infection | Day 8 |
| Number of Patients With Pain Relief | 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. | Day 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
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| Secondary | Patient Satisfaction Score | 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. | 3 participants did not complete their survey. Each participant received one lead secured with suture only and a second lead secured with both suture and Dermabond. The patient served as their own control. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
| Secondary | Rate of Infection | percent of participants with a higher rate of infection | Posted | Number | percent of participants | Day 8 |
|
|
|
| Secondary | Number of Patients With Pain Relief | 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. | Posted | Number | participants | Day 8 |
|
|
|
| Other Pre-specified | Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray | Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray | Not Posted | Day 8 | Participants |
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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