Clinical trial NCT00205855: An Implantable Spinal Cord Stimulation Pain Management System
Official title: Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Pain, Intractable
Pain
Back Pain
Failed Back Surgery Syndrome
Keywords: Pain
Chronic Pain
Neurostimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial 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: Dailed back surgery syndrome, intractable low backpain and leg pain.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Be an appropriate candidate for surgery.
3. Be capable of giving informed consent.
4. Be capable and willing to follow all study related procedures.

Exclusion Criteria:

1. Have an inability to operate the system either by self or care-giver.
2. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
3. Have any implanted electrical devices, regardless of whether active or inactive.
4. Have any active implantable device regardless of whether stimulation is ON or OFF.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
timeFrame: 2 weeks post initial fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Pain Center
state: Alabama
city: Los Angeles
country: United States
facility: California Pain Medicine Centers
state: California
city: San Francisco
country: United States
facility: Pacific Pain Treatment Center
state: California
city: Billings
country: United States
facility: Yellowstone Neurological Associates
state: Montana
city: Syosset
country: United States
facility: Northshore University Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Dallas Neurological Associates
state: Texas
city: Houston
country: United States
facility: River Oaks Pain Management
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: Boston Scientific Corporation
name: Kay Adair
role: STUDY_CHAIR
References: