A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

An observational study of Chronic Pain, run by Abbott Medical Devices at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Implantation with the commercially available Axium neurostimulator
Type of treatment: Medical device
How many people: 66 participants
Where: 2 sitesNetherlands
Study dates: Apr 2012to Jul 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 Pain Patients

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 thoracic, lumbar and/or sacral distribution(s) 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
In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
Subject is able to provide written informed consent
Subject speaks Dutch or English

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
Patient has pain only or primarily within a cervical dermatomal distribution

Show all 13Show fewer

Subject is unable to operate the device
Subjects with indwelling devices that may pose an increased risk of infection
Subjects currently has an active infection
Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
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

2 sites in 1 country.

Netherlands2 sites

St Antonius Ziekenhuis
Nieuwegein
Erasmus MC Pijnbehandelcentrum
Rotterdam

Other trials in Netherlands

About this study

Official title: A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.

Conditions: Chronic Pain
Being tested: Implantation with the commercially available Axium neurostimulator
Medical subject headings: Chronic Pain

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 groups in NCT02335502
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 pain) to 10 (maximum pain).
Measured: 3, 6 and 12-Months
Percentage of Subjects With at Least 50% Pain Reduction
Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.
Measured: Baseline and End of Trial Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jul 2015

First posted9 Jan 2015 (estimated)
Study startApr 2012
Primary completionJun 2015
Study completionJul 2015

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 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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02335502
Sponsor's protocol ID: 04-SMI-2012
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

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 Intractable Pain
ClinicalTrials.gov ID: NCT02335502
Acronym / sponsor ID: 04-SMI-2012
Conditions: Chronic Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 9 Jan 2015 (estimated)
Results: Posted 3 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.

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 Pain Patients

Key inclusion criteria (8 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 thoracic, lumbar and/or sacral distribution(s) 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 (13 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: 3, 6 and 12-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 pain) to 10 (maximum pain).
Percentage of Subjects With at Least 50% Pain Reduction
Time frame: Baseline and End of Trial Visit
Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.

Results and safety

Results posted to the registry on 3 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Subjects	66	49

Primary outcome: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline

Time frame: 3, 6 and 12-Months. Mean (Standard Deviation). Unit: units on a scale

Measure	Subjected Treated With the Permanent Implantable Axium System n = 56
Baseline	7.4 (1.41)
3-Months	3.9 (2.63)
6-Months	4.5 (2.84)
12-Months	4.7 (2.87)

Population analysed: Differences in participants over time is due to early withdrawals and missing data

Primary outcome: Percentage of Subjects With at Least 50% Pain Reduction

Time frame: Baseline and End of Trial Visit. Count of participants. Unit: Participants

Measure	Subjected Treated With the Permanent Implantable Axium System n = 47
>= 50% Pain Reduction	29
< 50% Pain Reduction	18

Population analysed: All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.

Adverse events

Time frame: All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	8 of 66 (12.1%)	7 of 66 (10.6%)	Not reported

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.

Related trials for Chronic Pain

Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
RecruitingObservational study
Different Treatments in Chronic Pain Patients.
Chronic Pain, Nociplastic Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain

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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Abbott Medical Devices at 2 sites in Netherlands.

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 8 inclusion and 13 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 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 2 sites in Netherlands. 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 3 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: 3, 6 and 12-Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02335502.

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; AzTrials last refreshed its copy on 3 Nov 2026.