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

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