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

Study Overview
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Brief Summary
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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.

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

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 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 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 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 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

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 |
| --- | --- | --- |
| 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). | 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. | Baseline and End of Trial Visit |