PainPhase 4NCT00399516
Effect of Pulse Width With Spinal Cord Stimulation
A Phase 4 study testing Precision in people with Pain and Chronic Pain, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Back Pain
- What is being tested?
- Precision
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2007
- Phase
- Phase 4
- 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
- Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
- Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
- Be 18 years of age or older.
- Be willing and able to comply with all study related procedures and visits.
- Be capable of reading and understanding patient information materials and giving written informed consent.
Who cannot join
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have any other chronic pain condition likely to confound evaluation of study endpoints.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Pain Management and Rehabilitation
Daphne, Alabama, 36526
About this study
Official title: The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
Read the detailed description
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.
Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
- Conditions
- Pain, Chronic Pain, Back Pain
- Being tested
- Precision
- Keywords
- Pain, Neurostimulation, Back pain, Chronic Pain
- Medical subject headings
- Pain, Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecisionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Measured: Within 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2007
- Study completionNov 2007
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 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Yearwood, MD, Principal investigator, Comprehensive Pain and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399516
- Sponsor's protocol ID
- SCS0706
- Status last verified
- Mar 2012
- First submitted
- 13 Nov 2006
- Last updated
- 4 Apr 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 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT00399516
- Acronym / sponsor ID
- SCS0706
- Conditions
- Pain, Chronic Pain, Back Pain
- Keywords
- Pain, Neurostimulation, Back pain, Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Posted 4 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
Detailed description
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.
Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
- Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
- Be 18 years of age or older.
- Be willing and able to comply with all study related procedures and visits.
- Be capable of reading and understanding patient information materials and giving written informed consent.
Key exclusion criteria (2 listed)
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have any other chronic pain condition likely to confound evaluation of study endpoints.
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 | Device | – |
Primary outcome
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Time frame: Within 6 months post-implantation
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
Thomas Yearwood, MD principal investigator
Comprehensive Pain and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precision in people with Pain and Chronic Pain, run by Boston Scientific Corporation at 1 site 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 5 inclusion and 2 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 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 4 Apr 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?
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) (time frame: Within 6 months post-implantation). 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 4 Apr 2012.