An Implantable Spinal Cord Stimulation Pain Management System
Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System
1 other identifier
interventional
65
1 country
9
Brief Summary
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-pain
Started Feb 2003
Typical duration for phase_3 chronic-pain
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedResults Posted
Study results publicly available
October 26, 2012
CompletedOctober 26, 2012
September 1, 2012
8 months
September 13, 2005
March 5, 2012
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
2 weeks post initial fitting
Study Arms (1)
Precision SCS
EXPERIMENTALPrecision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system
Interventions
Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Eligibility Criteria
You may qualify if:
- Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
- Be an appropriate candidate for surgery.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
You may not qualify if:
- Have an inability to operate the system either by self or care-giver.
- Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
- Have any implanted electrical devices, regardless of whether active or inactive.
- Have any active implantable device regardless of whether stimulation is ON or OFF.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Alabama Pain Center
Huntsville, Alabama, 35801, United States
California Pain Medicine Centers
Los Angeles, California, 90059, United States
Pacific Pain Treatment Center
San Francisco, California, 94109, United States
Yellowstone Neurological Associates
Billings, Montana, 59101, United States
Northshore University Hospital
Syosset, New York, 11791, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Dallas Neurological Associates
Dallas, Texas, 75231, United States
River Oaks Pain Management
Houston, Texas, 77027, United States
Texas Back Institute
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Natalie Bloom Lyons
- Organization
- Boston Scientific Corporation
Study Officials
- STUDY CHAIR
Kay Adair
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
February 1, 2003
Primary Completion
October 1, 2003
Study Completion
March 1, 2005
Last Updated
October 26, 2012
Results First Posted
October 26, 2012
Record last verified: 2012-09