Chronic PainPREDICTNCT02169401

A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain

An observational study of Chronic Pain, run by Abbott Medical Devices at 1 site in United Kingdom.

Completed

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

Trial summary

08-SMI-2012 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: 135 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2012to 25 Jan 2017
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
Average 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

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 DRG 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 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 trial 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.

United Kingdom1 site

James Cook University Hospital
Middlesbrough, TS4 3BW

Other trials in United Kingdom

About this study

Official title: a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium

08-SMI-2012 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 NCT02169401
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 Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain.
Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., \& French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.
Measured: Post implantation at; 1, 3, 6, 12 and 24 months

Timeline

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

Nov 201225 Jan 2017

First posted23 Jun 2014 (estimated)
Study startNov 2012
Primary completion25 Jan 2017
Study completion25 Jan 2017

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: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02169401
Sponsor's protocol ID: 08-SMI-2012 - PREDICT
Acronym: PREDICT
Status last verified: Sep 2024
First submitted: 13 Jun 2014
Last updated: 14 Nov 2024
Results posted: Yes, on ClinicalTrials.gov

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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
ClinicalTrials.gov ID: NCT02169401
Acronym / sponsor ID: PREDICT / 08-SMI-2012 - PREDICT
Conditions: Chronic Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: 25 Jan 2017 (actual)
Study completion: 25 Jan 2017 (actual)
First posted: 23 Jun 2014 (estimated)
Results: Posted 14 Nov 2024

Clinical summary

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

08-SMI-2012 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 (7 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
Average 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 DRG 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

Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
Time frame: Post implantation at; 1, 3, 6, 12 and 24 months
The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., \& French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.

Results and safety

Results posted to the registry on 14 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated Subjects	135	108

Primary outcome: Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation

Time frame: Post implantation at; 1, 3, 6, 12 and 24 months. Mean (Standard Deviation). Unit: cm

Measure	Treated Subjects n = 135
Baseline	7.5 (1.7)
1-Month Visit	4.4 (2.8)
3-Month Visit	5.2 (2.5)
6-Month Visit	4.7 (2.6)
12-Month Visit	4.9 (2.8)
24-Month Visit	4.4 (2.8)

Population analysed: Subject attrition reduced the number of participating and analyzable subjects at all subsequent visits post-implant.

Adverse events

Time frame: Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Subjects	4 of 135 (3%)	35 of 135 (25.9%)	2 of 135

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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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.

S ElDabe, Prof principal investigator

James Cook University Hospital

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 Pain, run by Abbott Medical Devices at 1 site in United Kingdom.

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 7 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: finished, as of the sponsor's last update on 14 Nov 2024. 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 Kingdom. 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 14 Nov 2024). 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 Relief- Change in VAS Pain Intensity From Baseline to Post Implantation (time frame: Post implantation at; 1, 3, 6, 12 and 24 months). 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 NCT02169401.

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 14 Nov 2024.