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Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

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ClinicalTrials.gov Identifier: NCT00370773
Recruitment Status : Terminated (Slow Enrolling)
First Posted : September 1, 2006
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:
Boston Scientific Corporation

Brief Summary:
This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.

Condition or disease Intervention/treatment Phase
Back Pain Device: Precision Spinal Cord Stimulation System Phase 4

Detailed Description:
This study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (INRS) in treating back pain. The efficacy of this strategy will be tested against dorsal column stimulation (DCS), the commonly-accepted technique for spinal cord stimulation. DCS will be tested at subthreshold and suprathreshold (perceptible) amplitudes. A substudy will involve patients who prefer suprathreshold DCS over INRS and subthreshold DCS. Its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. The overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Treatment of Chronic Low Back Pain With Spinal Cord Stimulation: Comparison of Subthreshold Intraspinal Nerve Root Stimulation With Subthreshold and Suprathreshold Dorsal Column Stimulation and a Secondary Study of the Effect of Pulse Width
Study Start Date : January 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources




Primary Outcome Measures :
  1. The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS). [ Time Frame: 1 year ]
  2. The primary safety endpoint is incidence of adverse events. [ Time Frame: Throughout Study ]

Secondary Outcome Measures :
  1. The secondary objectives of this study are to assess the effect of different stimulation types on average pain and pain-related disability, and to assess the subjective comfort of paresthesia with different pulse widths. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome.
  • Be an appropriate candidate for Spinal Cord Stimulation (SCS) and for the surgical procedures required for SCS.
  • Have experienced significant though short-lived pain relief with local anesthetic injection.
  • Be 18 years of age or older.
  • Be willing and able to comply with all study related procedures and visits.
  • Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

  • Have any significant medical condition that is likely to interfere with study procedures.
  • Have any evidence of neurologic instability.
  • Have any other chronic pain condition.
  • Have a condition currently requiring or likely to require the use of MRI or diathermy.
  • Have an active implantable device.
  • Are pregnant or planning to become pregnant in the next year.
  • Are a current substance abuser (including alcohol and illicit drugs).
  • Have a significant psychiatric disorder.
  • Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370773


Locations
United States, Alabama
Comprehensive Pain & Rehabilitation
Daphne, Alabama, United States, 36526
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Thomas Yearwood, MD Comprehensive Pain and Rehabilitation

Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00370773     History of Changes
Other Study ID Numbers: SCS0705
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: August 2008

Keywords provided by Boston Scientific Corporation:
Failed Back Surgery Syndrome
Back Pain
Chronic Pain
Spinal Cord Stimulation

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms