A Post Market Study to Assess the Spinal Modulation Neurostimulator System for 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Antonius Ziekenhuis, Nieuwegein, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation with the commercially available Axium neurostimulator

Device

Primary outcomes

Change in Pain Intensity for Overall Pain From Pre-treatment Baseline

Time frame: 3, 6 and 12-Months

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).
Percentage of Subjects With at Least 50% Pain Reduction

Time frame: Baseline and End of Trial Visit

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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jan 9, 2015
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed