NCT01126983

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

1 month

First QC Date

May 16, 2010

Last Update Submit

July 7, 2010

Conditions

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

  • Migration of leads with different methods of securing leads during spinal cord stimulation trial period.

    3-5 days

Study Arms (1)

Non-Suture

EXPERIMENTAL

No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms.

Device: SutureDevice: Lead Anchor

Interventions

SutureDEVICE

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.

Also known as: 2.0 Mono-filament nylon suture
Non-Suture
Lead AnchorDEVICE

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.

Also known as: 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106
Non-Suture

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients undergoing Spinal Cord Stimulation (age \> 18yrs)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Care of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

Location

Related Publications (9)

  • 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. doi: 10.3171/spi.2004.100.3.0254.

    PMID: 15029914BACKGROUND

  • 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. doi: 10.1056/NEJMc055504. No abstract available.

    PMID: 16738284BACKGROUND

  • 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.

    PMID: 19769908BACKGROUND

  • 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. doi: 10.1007/978-3-7091-9419-5_26.

    PMID: 8748598BACKGROUND

  • 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. doi: 10.1016/s1529-9430(01)00083-3.

    PMID: 14588316BACKGROUND

  • 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.

    PMID: 19096610BACKGROUND

  • 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. doi: 10.3171/spi.2006.5.3.183.

    PMID: 16961078BACKGROUND

  • 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. doi: 10.3171/spi.2006.5.3.191.

    PMID: 16961079BACKGROUND

  • 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.

    PMID: 18476899BACKGROUND

Related Links

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Edward Shadid, M.D

    Spine Care of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2010

First Posted

May 20, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

US(1)