- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335216
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS) (SYMPATHY)
October 4, 2019 updated by: Abbott Medical Devices
A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY
18-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 pain following lumbar discectomy (Failed Back Surgery Syndrome)
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nieuwegein, Netherlands
- St Antonius Ziekenhuis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients suffering from chronic pain post discectomy surgery
Description
Inclusion Criteria:
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic pain following surgical lumbar discectomy 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 subjects primary area of pain
- Subject is able to provide written informed consent
Exclusion Criteria:
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- 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
- 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 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.
- Subject has an anatomical spinal abnormality which is anticipated to require further surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treated Subjects
All subjects recruited and treated with the Axium neurostimulator
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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
Time Frame: Baseline, 3, 6 and 12 Months
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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).
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Baseline, 3, 6 and 12 Months
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Percentage of Subjects With at Least 50% Pain Reduction
Time Frame: 3, 6 and 12-Month Visits
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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 and 12-Month Visits
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
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)
October 16, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-SMI-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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