Failed back surgery syndrome Surgery
Conditions
Interventions
Eligible subjects with predominant back pain after a failed back surgery will undergo a trial of Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy) as per the center’s usual practice. Successfully
Sponsors
Nevro Corp (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with failed back surgery syndrome with predominant back pain 2. Average back pain intensity of = 5 out of 10 on the Numeric Rating Scale (NRS) at enrollment 3. An appropriate candidate for Spinal Cord Stimulation as per the Belgian regulations 4. An adult (= 18 years of age) at time of enrollment 5. Evaluated at the investigational site at least once prior to screen for the pain condition related to the study 6. Willing and capable of giving written informed consent prior to any investigational related procedure 7. Willing and able to comply with study-related requirements, assessments and visits 8. Capable of subjective evaluation, able to read and understand written questionnaires, and able to read, understand and sign the written inform consent (Dutch and French) 9. Adequate cognitive ability to use a patient external trial stimulator and recharger as determined by the Investigator 10. An appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician and if applicable per the local regulations 11. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the baseline visit 12. A stable physical activity level, as determined by the Investigator and activity diary, for at least 2 weeks prior to the baseline visit
Exclusion criteria
Exclusion criteria: 1. Using an daily opioid dose of >60mg oral morphine equivalents (meq) or daily >25 µg/hr transdermal fentanyl 2. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints 3. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist 4. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis 5. A visceral pain in the area being treated 6. A current diagnosis of a coagulation disorder, Complex Regional Pain Syndrome (CRPS), bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus 7. A diagnosis of scoliosis that precludes lead placement 8. Recent evidence (imaging or letter neurosurgeon) of spinal instability requiring fusion (imaging such as flexion/extension films of lumbar spine is required for this determination and must have been done within the past 6 months) 9. Pain that is significantly exacerbated by activity or significantly alleviated by rest 10. Benefiting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain 11. An existing drug pump and/or SCS system or another active implantable device (switched on or off) such as a pacemaker or other SCS devices 12. Prior experience with SCS 13. A condition currently requiring or likely to require the use of MRI in the trunk 14. Metastatic malignant disease or active local malignant disease 15. A life expectancy of less than 1 year 16. An active systemic or local infection 17. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) 18. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 19. Limited physical activity not due to back pain (due to e.g. knee arthrosis, arthroplasty) 20. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study and/or data collection 21. Involved in an injury claim under current litigation 22. A pending or approved worker’s compensation claim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Back pain intensity assessed by numeric rating scale (NRS) at baseline, at the end of the trial and at post-IPG monthly follow-up visits (1, 2, 3, 4, 5 and 6 months) 2. Leg pain intensity assessed by NRS at baseline, at the end of the trial and at post-IPG monthly follow-up visits (1, 2, 3, 4, 5 and 6 months) 3. Pain quality assessed by SF-MPQ at baseline, at the end of the trial and at post-IPG 3 and 6 month follow-up visits 4. Neurological assessment at baseline and at post-IPG 3 month follow-up visit 5. Level of catastrophic thinking assessed by the Pain Catastrophizing Scale – PCS at baseline, at the end of the trial and at post-IPG 3 and 6 month follow-up visits 6. Emotional mood assessed by the State Trait Anxiety Inventory – STAI Y1-Y2 at baseline, at the end of the trial, and at post-IPG follow-up visits 7. Assessment of the subject’s condition and device use during follow-up, performed during the Weekly Telephone Interview (NRS pain, physical activity, medication use, adverse events, device usage) 8. Depression assessed by the Beck Depression Inventory – BDI-II at baseline, at the end of the trial, and at post-IPG 3 and 6 month follow-up visits 9. Assessment of the subject’s expectation with therapy assessed by NRS rating at enrolment 10. Assessment of the subject’s fulfillment of his expectation at the end of the trial and post-IPG monthly follow-up visits (1, 2, 3, 4, 5 and 6 months), assessed by NRS rating 11. General state of health assessed by the Patient Global Impression of Change instrument - PGIC at baseline, at the end of the trial and at post-IPG 3, 4 and 6 month follow-up visits 12. General state of health assessed by the Clinician Global Impression of Change instrument - CGIC at baseline, at the end of the trial and at post-IPG 3, 4 and 6 month follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Belgium
Contacts
Public ContactBrad Gliner
Outcome results
None listed