Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

NCT00370773 | Terminated Phase 4

• 1 other identifier: SCS0705
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.

Conditions

Back Pain

Keywords

Failed Back Surgery Syndrome; Back Pain; Chronic Pain; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (2)

• The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).

  1 year

• The primary safety endpoint is incidence of adverse events.

  Throughout Study

Secondary Outcomes (1)

• The secondary objectives of this study are to assess the effect of different stimulation types on average pain and pain-related disability, and to assess the subjective comfort of paresthesia with different pulse widths.

  1 year

Interventions

Precision Spinal Cord Stimulation System DEVICE

Eligibility Criteria

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

You may qualify if:

• Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome.
• Be an appropriate candidate for Spinal Cord Stimulation (SCS) and for the surgical procedures required for SCS.
• Have experienced significant though short-lived pain relief with local anesthetic injection.
• 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 any significant medical condition that is likely to interfere with study procedures.
• Have any evidence of neurologic instability.
• Have any other chronic pain condition.
• Have a condition currently requiring or likely to require the use of MRI or diathermy.
• Have an active implantable device.
• Are pregnant or planning to become pregnant in the next year.
• Are a current substance abuser (including alcohol and illicit drugs).
• Have a significant psychiatric disorder.
• Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Comprehensive Pain & Rehabilitation

Daphne, Alabama, 36526, United States

Location

MeSH Terms

Conditions

Back Pain; Failed Back Surgery Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Thomas Yearwood, MD

  Comprehensive Pain and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: September 1, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2007
• Last Updated: September 5, 2008

Record last verified: 2008-08

Locations

US (1)