Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor

Study Overview
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Brief Summary
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To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period. Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.

Detailed Description
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Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin. Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are suturing the leads using 2.0 mono-filament nylon to the skin, suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin, non- suture. In all three groups copious amounts of benzoin and steri-strips will be used. Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.

Official Title
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Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor Securing Methods: A Randomized Single Blind Clinical Trial for Better Outcomes.

Conditions
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Spinal Cord Stimulation

Intervention / Treatment
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* Device: Suture
* Device: Lead Anchor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients undergoing Spinal Cord Stimulation (age > 18yrs) Exclusion Criteria: patients whose trial period lasts less than 3 days or more than 5 days will be excluded from the study. patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Suture<br>No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms. | Device: Suture<br>* Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.<br>* Other names: 2.0 Mono-filament nylon suture;Device: Lead Anchor<br>* Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.<br>* Other names: 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of leads with different methods of securing leads during spinal cord stimulation trial period. |  | 3-5 days |