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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision SCS | Experimental | Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision SCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kay Adair | Boston Scientific Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Pain Center | Huntsville | Alabama | 35801 | United States | ||
| California Pain Medicine Centers |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation (SCS) Group | Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered "trial" durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation (SCS) Group | Precision Spinal Cord Stimulation therapy group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants with > 50% VAS improvement | 2 weeks post initial fitting |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Cord Stimulation (SCS) Group | Precision Spinal Cord Stimulation therapy group | 12 | 65 | 20 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Migration | Surgical and medical procedures | Non-systematic Assessment |
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| Loss of Therapy | Surgical and medical procedures | Non-systematic Assessment |
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| New Lead Placement | Surgical and medical procedures | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Implantable Pulse Generator Movement | Surgical and medical procedures | Non-systematic Assessment |
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| Pain | Surgical and medical procedures | Non-systematic Assessment |
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| Device Malfunction | Surgical and medical procedures | Non-systematic Assessment |
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| Death | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Died in t he hospital due to complications of a broken hip |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abstinence syndrome | Nervous system disorders | Non-systematic Assessment |
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| CSF leak | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Lead Migration | Surgical and medical procedures | Non-systematic Assessment |
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| Device Malfunction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Grand-Mal Seizure | Nervous system disorders | Non-systematic Assessment |
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| Nausea & Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Reduced Telemetry Range | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Seroma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pain during SCS Trial | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Over and Under stimulation during SCS Trial | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Unpleasant Stimulation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | 763-228-9040 | lyonsn@bsci.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010148 | Pain, Intractable |
| D010146 | Pain |
| D001416 | Back Pain |
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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