Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

Back Pain Clinical Trial

Official title:

Treatment of Chronic Low Back Pain With Spinal Cord Stimulation: Comparison of Subthreshold Intraspinal Nerve Root Stimulation With Subthreshold and Suprathreshold Dorsal Column Stimulation and a Secondary Study of the Effect of Pulse Width

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00370773
• Other study ID #: SCS0705
• Status: Terminated
• Phase: Phase 4
• First received: August 30, 2006
• Last updated: September 4, 2008
• Start date: January 2006
• Est. completion date: February 2007

Study information

• Verified date: August 2008
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (INRS) in treating back pain. The efficacy of this strategy will be tested against dorsal column stimulation (DCS), the commonly-accepted technique for spinal cord stimulation. DCS will be tested at subthreshold and suprathreshold (perceptible) amplitudes. A substudy will involve patients who prefer suprathreshold DCS over INRS and subthreshold DCS. Its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. The overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• Precision Spinal Cord Stimulation System

Locations

Country	Name	City	State
United States	Comprehensive Pain & Rehabilitation	Daphne	Alabama

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 objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).		1 year	No
Primary	The primary safety endpoint is incidence of adverse events.		Throughout Study	Yes
Secondary	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	No