A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic 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: 41 participants
Where: 2 sitesSweden
Study dates: Apr 2013to Dec 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 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 VAS 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 or plans to become pregnant during the study duration
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 DRG within the past 3 months
Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
Subject is unable to operate the device

Show all 10Show fewer

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

2 sites in 1 country.

Sweden2 sites

Sahlgrenska Universitetssjukhuset
Gothenburg
Akademiska sjukhuest
Uppsala

Other trials in Sweden

About this study

Official title: BINGO: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic 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 NCT02346643
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.

Pain Intensity in Primary Region of Pain
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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: Post treatment at 3, 6 and 12 months
Pain Intensity in Overall Pain
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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: Post treatment at 3, 6 and 12 months

Timeline

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

Apr 2013Dec 2015

First posted27 Jan 2015 (estimated)
Study startApr 2013
Primary completionDec 2015
Study completionDec 2015

Why it stopped: Budget Allocation Decision by Sponsor

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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02346643
Sponsor's protocol ID: 11-SMI-2013
Acronym: BINGO
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: BINGO: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region
ClinicalTrials.gov ID: NCT02346643
Acronym / sponsor ID: BINGO / 11-SMI-2013
Conditions: Chronic Pain
Study type: Observational
Recruitment status: TerminatedReason stopped: Budget Allocation Decision by Sponsor
Enrolment: 41 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

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

11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic 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 (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 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 VAS in the primary region of pain

Key exclusion criteria (10 listed)

Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
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 DRG within the past 3 months
Subject currently has an active implantable device including ICD, 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

Pain Intensity in Primary Region of Pain
Time frame: Post treatment at 3, 6 and 12 months
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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).
Pain Intensity in Overall Pain
Time frame: Post treatment at 3, 6 and 12 months
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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).

Results and safety

Results posted to the registry on 19 Feb 2018, 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	41	6

Primary outcome: Pain Intensity in Primary Region of Pain

Time frame: Post treatment at 3, 6 and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Subjected Treated With the Permanent n = 31
Baseline	7.6 (1.3)
3-Month Visit	4.9 (2.4)
6-Month Visit	5.3 (2.7)
12-Month Visit	4.8 (2.8)

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

Primary outcome: Pain Intensity in Overall Pain

Time frame: Post treatment at 3, 6 and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Subjected Treated With the Permanent n = 31
Baseline	7.5 (1.5)
3-Month Visit	5.3 (2.3)
6-Month Visit	5.4 (2.8)
12-Month Visit	5.6 (2.3)

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

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	1 of 41 (2.4%)	7 of 41 (17.1%)	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

Recruiting
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Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
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Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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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.

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 Sweden.

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 10 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 2 sites in Sweden. 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 Feb 2018). 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 Intensity in Primary Region of Pain (time frame: Post treatment at 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 NCT02346643.

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.