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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-01-25

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.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated subjects

All subjects recruited and treated with the Axium Neurostimulator

Implantation with the commercially available Axium Neurostimulator

Intervention Type DEVICE

Interventions

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Implantation with the commercially available Axium Neurostimulator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No