Effect of Pulse Width With Spinal Cord Stimulation
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ClinicalTrials.gov Identifier: NCT00399516 |
Recruitment Status
:
Completed
First Posted
: November 15, 2006
Results First Posted
: April 4, 2012
Last Update Posted
: April 4, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Chronic Pain Back Pain | Device: Precision | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | November 2007 |

- 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"

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399516
United States, Alabama | |
Comprehensive Pain Management and Rehabilitation | |
Daphne, Alabama, United States, 36526 |
Principal Investigator: | Thomas Yearwood, MD | Comprehensive Pain and Rehabilitation |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00399516 History of Changes |
Other Study ID Numbers: |
SCS0706 |
First Posted: | November 15, 2006 Key Record Dates |
Results First Posted: | April 4, 2012 |
Last Update Posted: | April 4, 2012 |
Last Verified: | March 2012 |
Keywords provided by Boston Scientific Corporation:
Pain Neurostimulation Back pain Chronic Pain |
Additional relevant MeSH terms:
Back Pain Chronic Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |