A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)

NCT02634398 | Withdrawn

• 1 other identifier: 26-SMI-2015
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Assessed by change in pain intensity on a Visual Analogue Scale (VAS) from pre-treatment baseline

  Post implantation at; 1 week and 1, 3, 6 and 12 months

Study Arms (1)

Treated subjects

All subjects recruited and treated wiht the Axium neurostimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from chronic pain post discectomy surgery

You may qualify if:

• 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 VAS in the subjects' primary area of pain
• Subject is able to provide written informed consent

You may not qualify if:

• 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 DRG within the past 3 months
• Subject currently has an active implantable device including ICD, 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Centre d'Antalgie de l'EHC-Hôpital de Morges

Morges, Canton of Vaud, 1110, Switzerland

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

CH (1)