N/A
Completed N=66
A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain
Source: ClinicalTrials.gov NCT02335502 ↗Enrolled (actual)
66
Serious AEs
12.1%
Results posted
Aug 2017
Primary outcomePrimary: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline — 7.4; 3.9; 4.5; 4.7 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity for Overall Pain From Pre-treatment Baseline |
7.4; 3.9; 4.5; 4.7 | — |
| PRIMARY Percentage of Subjects With at Least 50% Pain Reduction |
29; 18 | — |
Eligibility Criteria
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 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
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 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
Data sourced from ClinicalTrials.gov (NCT02335502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.