A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain
- Conditions
- Chronic Pain
- Interventions
- Device: Implantation with the commercially available Axium neurostimulator
- Registration Number
- NCT02335502
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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 Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3, 6 and 12-Months 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).
Percentage of Subjects With at Least 50% Pain Reduction Baseline and End of Trial Visit 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St Antonius Ziekenhuis
š³š±Nieuwegein, Netherlands
Erasmus MC Pijnbehandelcentrum
š³š±Rotterdam, Netherlands