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

Primary Purpose

Intractable Neuropathic Pain, Pain, Back Pain

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Precision for Spinal Cord Stimulation

About this trial

This is an interventional treatment trial for Intractable Neuropathic Pain focused on measuring Pain, Chronic Pain, Neurostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Anesthesia Associates of Belleville

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Stimulation will occur at the T7 followed by T8 during the trial implant period

Stimulation will occur at the T8 followed by T7 during the trial implant period

Outcomes

Primary Outcome Measures

The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.

Secondary Outcome Measures

Full Information

NCT ID

NCT00399841

First Posted

November 13, 2006

Last Updated

November 23, 2020

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00399841

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Investigator Resigned

Study Start Date

November 2006 (Actual)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain

Keywords

Pain, Chronic Pain, Neurostimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Stimulation will occur at the T7 followed by T8 during the trial implant period

Arm Title

Arm Type

Active Comparator

Arm Description

Stimulation will occur at the T8 followed by T7 during the trial implant period

Intervention Type

Device

Intervention Name(s)

Precision for Spinal Cord Stimulation

Intervention Description

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 Measure Information:

Title

The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.

Time Frame

End of trial (approximately 5 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roshini Jain

Organizational Affiliation

Boston Scientific Neuromodulation Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Anesthesia Associates of Belleville

City

Belleville

State/Province

Illinois

ZIP/Postal Code

62220

Country

United States

12. IPD Sharing Statement

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

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