An Implantable Spinal Cord Stimulation Pain Management System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Precision SCS Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system |
Device: Precision SCS
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. [2 weeks 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabama Pain Center | Huntsville | Alabama | United States | 35801 |
| 2 | California Pain Medicine Centers | Los Angeles | California | United States | 90059 |
| 3 | Pacific Pain Treatment Center | San Francisco | California | United States | 94109 |
| 4 | Yellowstone Neurological Associates | Billings | Montana | United States | 59101 |
| 5 | Northshore University Hospital | Syosset | New York | United States | 11791 |
| 6 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 7 | Dallas Neurological Associates | Dallas | Texas | United States | 75231 |
| 8 | River Oaks Pain Management | Houston | Texas | United States | 77027 |
| 9 | Texas Back Institute | Plano | Texas | United States | 75093 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Chair: Kay Adair, Boston Scientific Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-S-003
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 65 |
| COMPLETED | 44 |
| NOT COMPLETED | 21 |
Baseline Characteristics
| Arm/Group Title | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Arm/Group Description | Precision Spinal Cord Stimulation therapy group |
| Overall Participants | 65 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
54
83.1%
|
| >=65 years |
11
16.9%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52
(14)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
26
40%
|
| Male |
39
60%
|
| Region of Enrollment (participants) [Number] | |
| United States |
65
100%
|
Outcome Measures
| Title | Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks post initial fitting |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Arm/Group Description | Precision Spinal Cord Stimulation therapy group |
| Measure Participants | 46 |
| Number [participants with > 50% VAS improvement] |
35
53.8%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Spinal Cord Stimulation (SCS) Group | |
| Arm/Group Description | Precision Spinal Cord Stimulation therapy group | |
All Cause Mortality |
||
| Spinal Cord Stimulation (SCS) Group | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Spinal Cord Stimulation (SCS) Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/65 (18.5%) | |
| Infections and infestations | ||
| Infection | 2/65 (3.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Death | 1/65 (1.5%) | 1 |
| Surgical and medical procedures | ||
| Lead Migration | 5/65 (7.7%) | 5 |
| Loss of Therapy | 1/65 (1.5%) | 1 |
| New Lead Placement | 2/65 (3.1%) | 2 |
| Implantable Pulse Generator Movement | 1/65 (1.5%) | 1 |
| Pain | 1/65 (1.5%) | 1 |
| Device Malfunction | 1/65 (1.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Spinal Cord Stimulation (SCS) Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/65 (30.8%) | |
| Gastrointestinal disorders | ||
| Nausea & Vomiting | 1/65 (1.5%) | 1 |
| Infections and infestations | ||
| Infection | 1/65 (1.5%) | 1 |
| Injury, poisoning and procedural complications | ||
| CSF leak | 3/65 (4.6%) | 3 |
| Device Malfunction | 8/65 (12.3%) | 8 |
| Reduced Telemetry Range | 1/65 (1.5%) | 1 |
| Pain during SCS Trial | 1/65 (1.5%) | 1 |
| Over and Under stimulation during SCS Trial | 4/65 (6.2%) | 4 |
| Unpleasant Stimulation | 2/65 (3.1%) | 2 |
| Nervous system disorders | ||
| Abstinence syndrome | 1/65 (1.5%) | 1 |
| Grand-Mal Seizure | 1/65 (1.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Seroma | 1/65 (1.5%) | 1 |
| Skin Irritation | 1/65 (1.5%) | 1 |
| Surgical and medical procedures | ||
| Lead Migration | 4/65 (6.2%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Natalie Bloom Lyons |
|---|---|
| Organization | Boston Scientific Corporation |
| Phone | 763-228-9040 |
| lyonsn@bsci.com |
- CR-S-003