Chronic Neuropathic PainNCT02335489
A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
An observational study of Chronic Neuropathic Pain, run by Abbott Medical Devices at 1 site in Belgium.
Trial summary
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neuropathic Pain
- What is being tested?
- Implantation with the commercially available Axium neurostimulator
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Nov 2015
- Phase
- Observational
- 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
Study population: Chronic Neuropathic Pain of the Foot and/or Lower Leg
Who may be able to join
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic, intractable pain in the foot and/or lower leg for at least 6 months
- Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
- Subject is able to provide written informed consent
Who cannot join
- Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
- Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
Show all 11Show fewer
- Subjects with indwelling devices that may pose an increased risk of infection
- Subjects currently has an active infection
- Subject has participated in another clinical investigation within 30 days
- Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- Subject has been diagnosed with cancer in the past 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
- Conditions
- Chronic Neuropathic Pain
- Being tested
- Implantation with the commercially available Axium neurostimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with the commercially available Axium neurostimulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Treated Subjects | All subjects recruited and treated with the Axium neurostimulator Receives: Device: Implantation with the commercially available Axium neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
Measured: Baseline, 3, 6 and12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months
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 Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335489
- Sponsor's protocol ID
- 14-SMI-2013
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2015
- Last updated
- 4 Feb 2019
- 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 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
- ClinicalTrials.gov ID
- NCT02335489
- Acronym / sponsor ID
- 14-SMI-2013
- Conditions
- Chronic Neuropathic Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Subjects | – | Device: Implantation with the commercially available Axium neurostimulatorAll subjects recruited and treated with the Axium neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Neuropathic Pain of the Foot and/or Lower Leg
Key inclusion criteria (6 listed)
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic, intractable pain in the foot and/or lower leg for at least 6 months
- Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
Key exclusion criteria (11 listed)
- Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
- Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
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 |
|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device | Treated Subjects |
Primary outcome
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
Time frame: Baseline, 3, 6 and12-Months
The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neuropathic Pain, run by Abbott Medical Devices at 1 site in Belgium.
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 6 inclusion and 11 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 4 Feb 2019. 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 Belgium. 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 2 Aug 2017). 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 Pain Intensity for Overall Pain From Pre-treatment Baseline (time frame: Baseline, 3, 6 and12-Months). 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 Feb 2019.