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Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00399841
Recruitment Status : Terminated (Investigator Resigned)
First Posted : November 15, 2006
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.

Condition or disease Intervention/treatment Phase
Intractable Neuropathic Pain Pain Back Pain Lower Extremity Pain Device: Precision for Spinal Cord Stimulation Not Applicable

Detailed Description:

The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites.

This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8
Actual Study Start Date : November 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Active Comparator: 1
Stimulation will occur at the T7 followed by T8 during the trial implant period
Device: Precision for Spinal Cord Stimulation
During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.

Active Comparator: 2
Stimulation will occur at the T8 followed by T7 during the trial implant period
Device: Precision for Spinal Cord Stimulation
During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.




Primary Outcome Measures :
  1. The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation. [ Time Frame: End of trial (approximately 5 days) ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy.
  • 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 sensory loss in the low back or lower extremity as the primary complaint.
  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
  • Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

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): NCT00399841


Locations
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United States, Illinois
Anesthesia Associates of Belleville
Belleville, Illinois, United States, 62220
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00399841    
Other Study ID Numbers: SCS0306
First Posted: November 15, 2006    Key Record Dates
Results First Posted: December 19, 2020
Last Update Posted: December 19, 2020
Last Verified: November 2020
Keywords provided by Boston Scientific Corporation:
Pain
Chronic Pain
Neurostimulation
Additional relevant MeSH terms:
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Neuralgia
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases