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

NCT00399841 | Terminated Results

• 1 other identifier: SCS0306
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Intractable Neuropathic Pain; Pain; Back Pain; Lower Extremity Pain

Keywords

Pain; Chronic Pain; Neurostimulation

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.

  End of trial (approximately 5 days)

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Precision for Spinal Cord Stimulation

2

ACTIVE COMPARATOR

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

Device: Precision for Spinal Cord Stimulation

Interventions

Precision for Spinal Cord Stimulation DEVICE

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Anesthesia Associates of Belleville

Belleville, Illinois, 62220, United States

Location

MeSH Terms

Conditions

Pain; Back Pain; Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

Insufficient data collected to report results

Results Point of Contact

• Title: Director, Clinical Research Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: November 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Locations

US (1)