A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain
This trial is active, not recruiting.
|Treatment||implantation with the commercially available axium neurostimulator|
|Sponsor||Spinal Modulation, Inc.|
|Start date||November 2012|
|End date||May 2017|
|Trial size||135 participants|
|Trial identifier||NCT02169401, 08-SMI-2012 - PREDICT|
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.
All subjects recruited and treated with the AxiumNeurostimulator
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
Male or female participants at least 18 years old.
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 VAS 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 ICD, 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
|Official title||a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium|
|Principal investigator||S ElDabe, Prof|
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