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

Spinal Cord Stimulation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126983
• Other study ID #: spinecareleads
• Status: Completed
• Phase: N/A
• First received: May 16, 2010
• Last updated: July 7, 2010
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Spine Care, Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. suturing the leads using 2.0 mono-filament nylon to the skin,

2. suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Stimulation

Intervention

Device:
• Suture
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.
• Lead Anchor
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.

Locations

Country	Name	City	State
United States	Spine Care of Oklahoma	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Spine Care, Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (9)

Brook AL, Georgy BA, Olan WJ. Spinal cord stimulation: a basic approach. Tech Vasc Interv Radiol. 2009 Mar;12(1):64-70. doi: 10.1053/j.tvir.2009.06.007. Review. — View Citation

Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. Review. — View Citation

Holsheimer J, Barolat G, Struijk JJ, He J. Significance of the spinal cord position in spinal cord stimulation. Acta Neurochir Suppl. 1995;64:119-24. — View Citation

Jang HD, Kim MS, Chang CH, Kim SW, Kim OL, Kim SH. Analysis of failed spinal cord stimulation trials in the treatment of intractable chronic pain. J Korean Neurosurg Soc. 2008 Feb;43(2):85-9. doi: 10.3340/jkns.2008.43.2.85. Epub 2008 Feb 20. — View Citation

Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Spinal cord stimulation for chronic reflex sympathetic dystrophy--five-year follow-up. N Engl J Med. 2006 Jun 1;354(22):2394-6. — View Citation

Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine. 2006 Sep;5(3):191-203. — View Citation

Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J. 2001 Sep-Oct;1(5):358-63. — View Citation

Park CH, Huh B. Lodged spinal cord stimulator trial lead: a case report. Pain Pract. 2008 May-Jun;8(3):210-3. doi: 10.1111/j.1533-2500.2008.00199.x. — View Citation

Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM. Failure modes of spinal cord stimulation hardware. J Neurosurg Spine. 2006 Sep;5(3):183-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration of leads with different methods of securing leads during spinal cord stimulation trial period.		3-5 days	No

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