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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Implantation with the commercially available Axium Neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated subjects<br>All subjects recruited and treated with the Axium Neurostimulator | Device: Implantation with the commercially available Axium Neurostimulator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief - Assessed by Change in Pain Intensity from Pre-Treatment Baseline |  | Post implantation at; 1 week and 1, 3, 6, 12 and 24 months |