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Completed

NCT Number: NCT00399516

Effect of Pulse Width With Spinal Cord Stimulation

The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

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Key information

Conditions

Pain Back Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Comprehensive Pain Management and Rehabilitation

Daphne, Alabama, 36526, United States

About this study

This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.

Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
  • Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
  • 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 or likely to confound evaluation of study endpoints.
  • Have any other chronic pain condition likely to confound evaluation of study endpoints.

Treatment and study plan

Precision

Device

Primary outcomes

  1. Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)

    Time frame: Within 6 months post-implantation

    Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2006
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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