Intractable Neuropathic PainNCT00399841
Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity
A study testing Precision for Spinal Cord Stimulation in people with Intractable Neuropathic Pain and Pain, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Neuropathic Pain, Pain, Back Pain
- What is being tested?
- Precision for Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2008
- Phase
- Interventional
- 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
- Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy.
- 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 sensory loss in the low back or lower extremity as the primary complaint.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anesthesia Associates of Belleville
Belleville, Illinois, 62220
About this study
Official title: Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.
Read the detailed description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites.
This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.
- Conditions
- Intractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain
- Being tested
- Precision for Spinal Cord Stimulation
- Keywords
- Pain, Chronic Pain, Neurostimulation
- Medical subject headings
- Pain, Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision for Spinal Cord StimulationDevice
During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Stimulation will occur at the T7 followed by T8 during the trial implant period Receives: Device: Precision for Spinal Cord Stimulation |
| 2 | Active comparator | Stimulation will occur at the T8 followed by T7 during the trial implant period Receives: Device: Precision for Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.
Measured: End of trial (approximately 5 days)
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 completionMay 2008
- Study completionNov 2008
Why it stopped: Investigator Resigned
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 Intractable Neuropathic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399841
- Sponsor's protocol ID
- SCS0306
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2006
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8
- ClinicalTrials.gov ID
- NCT00399841
- Acronym / sponsor ID
- SCS0306
- Conditions
- Intractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain
- Keywords
- Pain, Chronic Pain, Neurostimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Resigned
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Posted 19 Dec 2020
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 compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.
Detailed description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites.
This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Precision for Spinal Cord StimulationStimulation will occur at the T7 followed by T8 during the trial implant period |
| 2 | Active comparator | Device: Precision for Spinal Cord StimulationStimulation will occur at the T8 followed by T7 during the trial implant period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy.
- 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 (3 listed)
- Have sensory loss in the low back or lower extremity as the primary complaint.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
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 for Spinal Cord StimulationDuring Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on. | Device | 1, 2 |
Primary outcome
The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.
Time frame: End of trial (approximately 5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- 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.
Roshini Jain study director
Boston Scientific Neuromodulation Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision for Spinal Cord Stimulation in people with Intractable Neuropathic Pain and 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Dec 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2020). 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?
The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation. (time frame: End of trial (approximately 5 days)). 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 19 Dec 2020.