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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Back Pain; Lower Extremity Pain; Intractable Neuropathic Pain
• Intervention / Treatment: Device: Precision for Spinal Cord Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Belleville, Illinois, United States, 62220
      • Anesthesia Associates of Belleville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.	End of trial (approximately 5 days)

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 13, 2006
• First Submitted That Met QC Criteria: November 13, 2006
• First Posted (Estimate): November 15, 2006

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Chronic Pain; Neurostimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: SCS0306