pijn, specifiek rugpijn Chronic back pain Failed Back Surgery Syndrome
Conditions
Interventions
In this study there are two treatment arms:
• SQS arm = SQS + OMM
• OMM arm = OMM alone
Subjects randomized to the SQS arm will first undergo trial stimulation. Trial
stimulation must occur
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objective is to demonstrate that the proportion of subjects with a >=50% reduction in back pain intensity (Visual Analog Scale [VAS]) from baseline to the 9-month follow-up visit in the SQS arm is greater than that in the OMM arm. Primary endpoint: Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: 1. To demonstrate greater average decrease in back pain intensity (as measured by VAS) from baseline to the 9-month follow-up visit between the SQS and the OMM arms. 2. To demonstrate greater average decrease in back pain intensity (as measured by VAS) from baseline to the 6-month follow-up visit between the SQS and the OMM arms. 3. To assess the proportion of subjects with a >=50% reduction in back pain intensity (as measured by VAS) from baseline to the 6-month follow-up visit in the SQS and OMM arms. 4. To assess the proportion of subjects with a >=30% reduction in back pain intensity (as measured by VAS) from baseline to the 9-month follow-up visit in the SQS and OMM arms. Secondary endpoints: VAS Additional Outcome Measures Randomization Period: To Evaluate: 1. Average change in functional disability (as measured by the Oswestry Disability Index [ODI]) from baseline to the 9-month follow-up visit for subjects in the SQS arm compared to the OMM arm. 2. Change in health-related quality of life outcomes (as measured by the European Quality of Life Questionnaire [EQ-5D-5L]) from baseline to the 9-month follow-up visit for subjects in the SQS arm compared to the OMM arm. 3. Subject satisfaction with current therapy at the end of the 9-month follow-up visit for subjects in the SQS arm as compared to subjects in the OMM arm. 4. Change in quality of life (as measured by the SF-36 Health Survey) from baseline to the 9-month follow-up visit for subjects in the SQS arm compared to subjects in the CMM arm. 5. Study subject impression of change (as measured by the Patient Global Impression of Change [PGIC]) from baseline to the 9-month follow-up visit for subjects in the SQS arm compared to subjects in the OMM arm. 6. Healthcare resource utilization (HCU) from baseline to the 9-month follow-up visit for subjects in the SQS arm compared to subjects in the OMM arm. 7. Changes in pain medication and non-invasive p | — |
Countries
Netherlands
Outcome results
None listed