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

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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
Study Completion Date:	November 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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.
Active Comparator: 2 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

No publications provided

Responsible Party:	Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00399841 History of Changes
Other Study ID Numbers:	SCS0306
Study First Received:	November 13, 2006
Last Updated:	May 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Pain
Chronic Pain
Neurostimulation

Additional relevant MeSH terms:

Back Pain
Neuralgia
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 16, 2013