A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

Chronic Post Surgical Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02335229
• Other study ID #: 20-SMI-2013
• Status: Terminated
• Start date: June 2013
• Est. completion date: February 2017

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Post Surgical Pain

Intervention

Device:
• Axium DRG Neurostimulator
Implantation with Axium DRG Neurostimulator

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity for Overall Pain From Pre-treatment Baseline	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).	Baseline, 3, 6, 12 and 24-Month Visits
Primary	Percentage of Subjects With at Least 50% Pain Reduction	Percent of subjects with at least a 50% reduction. 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) to 10 (maximum).	3, 6, 12 and 24-Month Visits