Clinical trial NCT02335229: A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain
Official title: A Post Market Observational Cohort Study to Assess the Performance of the Spinal Modulation Dorsal Root Ganglion Stimulator System for the Management of Chronic Post Surgical Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Post Surgical Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-09
Enrollment: 30
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: Patient suffering from chronic post surgical pain

Brief summary: 20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical 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 post surgical pain 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. Subject is able to provide written informed consent
7. Pain medication dosage has been stable for at least 30 days
8. Patient has been included for implantation according to standard criteria from the Dutch Neuromodulation Society

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. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Patient has no other exclusion criteria according to standard criteria from the Dutch Neuromodulation Society

Primary outcomes:
measure: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
timeFrame: Baseline, 3, 6, 12 and 24-Month Visits
measure: Percentage of Subjects With at Least 50% Pain Reduction
timeFrame: 3, 6, 12 and 24-Month Visits
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
References: