A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

Abbott

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Implantation with the commercially available Axium neurostimulator

Study type: Observational

Funder types: Industry

Identifiers

NCT02335502

04-SMI-2012

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 in the thoracic, lumbar and/or sacral distribution(s) 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. Minimum 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
8. Subject speaks Dutch or English

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 Dorsal Root Ganglion 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. Patient has pain only or primarily within a cervical dermatomal distribution
7. Subject is unable to operate the device
8. Subjects with indwelling devices that may pose an increased risk of infection
9. Subjects currently has an active infection
10. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
11. Subject has participated in another clinical investigation within 30 days
12. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
13. Subject has been diagnosed with cancer in the past 2 years

Trial design

66 participants in 1 patient group

Treated Subjects

Description:

All subjects recruited and treated with the Axium neurostimulator

Treatment:

Device: Implantation with the commercially available Axium neurostimulator