SubQStim

Phase 4

Completed

• Conditions: pijn, specifiek rugpijn; Chronic back pain; Failed Back Surgery Syndrome

• Registration Number: NL-OMON41272
• Lead Sponsor: Medtronic B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Subject has signed and dated the Patient Informed Consent/Patient Information Sheet
2. Subject is minimum 18 years of age at the time of informed consent
4. Subject is willing and available toattend visits as scheduled and to comply with the study protocol
5. Subject is willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
6. Subject is willing and able to use the external 4neurostimulator, recharging equipment (if applicable) and patient programmer per the schedule required by the protocol
7. Subject has been diagnosed with FBSS (i.e.)
- has had persistent pain for 6 months following most recent anatomically correct, succesful surgery AND
- there is no clear surgical target on postoperative MR scan correlating to subject's pain
8. Based on the opinion of the Principal Investigator, subject's back pain is considered intractable and has been adequately treated, as defined by: 'Subject has failed an apropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical)'
9. Based on the opinion of the implanting physician, subject is an appropriate implant candidate for the SQS system

Exclusion Criteria

1.Subject has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
3. Subject has evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
4. Subject has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
5. Subject has evidence of spinal instability or anatomic compression that requires further surgery
6. Subject has had spinal fusion at more than 3 vertebral levels
7. Subject is currently enrolled in or plans to enroll in any current drug and/or device study that may confound the results of this study
8. Subject is allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
9. Subject has a history of coagulation disorder or lupus erythematosus
10. Subkect is involved in current litigation regarding back pain

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy objective is to demonstrate that the proportion of<br /><br>subjects with a >=50% reduction in back pain intensity (Visual Analog Scale<br /><br>[VAS]) from baseline to the 9-month follow-up visit in the SQS arm is greater<br /><br>than that in the OMM arm.<br /><br><br /><br>Primary endpoint: Visual Analog Scale (VAS)</p><br>