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

A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Implantation with the commercially available Axium neurostimulator

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus MC Pijnbehandelcentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic Pain Patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated Subjects; All subjects recruited and treated with the Axium neurostimulator	Device: Implantation with the commercially available Axium neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3, 6 and 12-Months
Percentage of Subjects With at Least 50% Pain Reduction	Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.	Baseline and End of Trial Visit

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pain, Intractable
• Other Study ID Numbers: 04-SMI-2012