Clinical trial NCT02335502: A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain
Official title: A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Pain Patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
timeFrame: 3, 6 and 12-Months
measure: Percentage of Subjects With at Least 50% Pain Reduction
timeFrame: Baseline and End of Trial Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC Pijnbehandelcentrum
Study officials:
References: