Chronic PainPhase 3NCT00205855
An Implantable Spinal Cord Stimulation Pain Management System
A Phase 3 study testing Precision SCS in people with Chronic Pain and Pain, Intractable, run by Boston Scientific Corporation at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pain, Intractable, Pain
- What is being tested?
- Precision SCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Yellowstone Neurological Associates
Billings, Montana, 59101
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas Neurological Associates
Dallas, Texas, 75231
River Oaks Pain Management
Houston, Texas, 77027
Alabama Pain Center
Huntsville, Alabama, 35801
California Pain Medicine Centers
Los Angeles, California, 90059
Texas Back Institute
Plano, Texas, 75093
Pacific Pain Treatment Center
San Francisco, California, 94109
Northshore University Hospital
Syosset, New York, 11791
About this study
Official title: Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System
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.
Read the 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.
- Conditions
- Chronic Pain, Pain, Intractable, Pain, Back Pain, Failed Back Surgery Syndrome
- Being tested
- Precision SCS
- Keywords
- Pain, Chronic Pain, Neurostimulation
- Medical subject headings
- Chronic Pain, Pain, Intractable, Pain, Back Pain, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision SCSDevice
Also called Stimulus System, PRECISION Spinal Cord Stimulator System (PRECISION System)
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision SCS | Experimental | Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system Receives: Device: Precision SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks post initial fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionOct 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Adair, Study chair, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205855
- Sponsor's protocol ID
- CR-S-003
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 26 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System
- ClinicalTrials.gov ID
- NCT00205855
- Acronym / sponsor ID
- CR-S-003
- Conditions
- Chronic Pain, Pain, Intractable, Pain, Back Pain, Failed Back Surgery Syndrome
- Keywords
- Pain, Chronic Pain, Neurostimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision SCS | Experimental | Device: Precision SCSPrecision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision SCSAlso: Stimulus System, PRECISION Spinal Cord Stimulator System (PRECISION System)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. | Device | Precision SCS |
Primary outcome
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay Adair study chair
Boston Scientific Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Precision SCS in people with Chronic Pain and Pain, Intractable, run by Boston Scientific Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. (time frame: 2 weeks post initial fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.