A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS) (SYMPATHY)

• ClinicalTrials.gov Identifier: NCT02335216
• Recruitment Status: Terminated
• First Posted: January 9, 2015
• Results First Posted: March 26, 2018
• Last Update Posted: October 16, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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)

Condition or disease	Intervention/treatment
Failed Back Surgery Syndrome	Device: Implantation with the commercially available Axium neurostimulator

Study Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Study Start Date: January 2014
• Actual Primary Completion Date: January 2017
• Actual Study Completion Date: January 2017

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Change in Pain Intensity for Overall Pain From Pre-treatment Baseline [ Time Frame: Baseline, 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).
2. Percentage of Subjects With at Least 50% Pain Reduction [ Time Frame: 3, 6 and 12-Month Visits ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from chronic pain post discectomy surgery

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 pain following surgical lumbar discectomy 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 subjects primary area of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
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. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Contacts and Locations

Locations

Netherlands

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Sponsors and Collaborators

Abbott Medical Devices

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02335216
• Other Study ID Numbers: 18-SMI-2013
• First Posted: January 9, 2015
• Results First Posted: March 26, 2018
• Last Update Posted: October 16, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Syndrome; Failed Back Surgery Syndrome; Disease; Pathologic Processes; Postoperative Complications; Back Pain; Pain; Neurologic Manifestations