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

Completed

Interventions: Device: Implantation with the commercially available Axium Neurostimulator

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treated subjects	Implantation with the commercially available Axium Neurostimulator	All subjects recruited and treated with the Axium Neurostimulator

Primary Outcome Measures

Name	Time	Method
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation	Post implantation at; 1, 3, 6, 12 and 24 months	The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., \& French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.

Secondary Outcome Measures