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

Pain Clinical Trial

Official title:

Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399841
• Other study ID #: SCS0306
• Status: Terminated
• Phase: N/A
• Start date: November 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Intractable Neuropathic Pain
• Lower Extremity Pain
• Neuralgia
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Anesthesia Associates of Belleville	Belleville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.		End of trial (approximately 5 days)