Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00399841

Purpose

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	Intervention	Phase
Intractable Neuropathic Pain Pain Back Pain Lower Extremity Pain	Device: Precision for Spinal Cord Stimulation	Phase IV

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

The primary efficacy endpoints are pain severity, quality and distribution of paresthesia, and satisfaction with treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain severity, quality and distribution of paresthesia, and satisfaction with treatment at 4, 12, 40, and 52 weeks post-activation as compared to baseline; [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Stimulation will occur at the 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.
2: Active Comparator Stimulation will occur at the T8 level 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399841

Locations

United States, Illinois
Pain Management Center
Belleville, Illinois, United States, 62226

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Eugene Pereira, MD

Pain Management Center

More Information

Responsible Party:	Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager )
Study ID Numbers:	SCS0306
Study First Received:	November 13, 2006
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00399841
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Pain
Chronic Pain
Neurostimulation

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009