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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169401
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Device: Implantation with the commercially available Axium Neurostimulator

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
Study Start Date : November 2012
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Treated subjects
All subjects recruited and treated with the Axium Neurostimulator
Device: Implantation with the commercially available Axium Neurostimulator

Primary Outcome Measures :
  1. Pain Relief - Assessed by Change in Pain Intensity from Pre-Treatment Baseline [ Time Frame: Post implantation at; 1 week and 1, 3, 6, 12 and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Pain Patients

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Subject is able and willing to comply with the follow-up schedule and protocol
  3. Chronic, intractable pain for at least 6 months
  4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
  5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
  6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
  7. Subject is able to provide written informed consent

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
  2. Escalating or changing pain condition within the past month as evidenced by investigator examination
  3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
  4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
  6. Subject is unable to operate the device
  7. Subjects currently has an active infection
  8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
  9. Subject has participated in another clinical trial within 30 days
  10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  11. Subject has been diagnosed with cancer in the past 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02169401

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United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: S ElDabe, Prof James Cook University Hospital
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Responsible Party: Abbott Medical Devices Identifier: NCT02169401    
Other Study ID Numbers: 08-SMI-2012 - PREDICT
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations