Chronic non-surgical refractory back pain Injury, Occupational Diseases, Poisoning Chronic non-surgical refractory back pain
Conditions
Interventions
Participants are randomly allocated in a 1:1 ratio to either the control or the intervention group:
Those in the intervention group receive the HF10 spinal cord stimulation therapy. T
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component 2. Have failed conventional medical treatments 3. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain 4. Demonstrating multi-level Degenerative Disc Disease and no current indication for referral for back surgery 5. Considering daily activity and rest, have average back pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment 6. Average back pain intensity greater than average leg pain intensity on the Visual Analog Scale (VAS) at enrollment 7. Be on stable pain medications, as determined by the Investigator 8. Be 18 years of age or older at the time of enrollment 9. Be willing and capable of giving informed consent 10. Be willing and able to comply with study-related requirements, procedures, and visits 11. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent
Exclusion criteria
Exclusion criteria: 1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders 2. Have a medical condition or pain in other area(s), not intended to be treated in this study 3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator 4. Have significant clinically mechanical spine instability 5. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain 6. Have an opioid addiction or drug seeking behavior as determined by the Investigator 7. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker 8. Have prior experience with neuromodulation devices 9. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guideline in the Physician’s Manual 10. Have metastatic malignant disease or active local malignant disease 11. Have a life expectancy of less than 2 years 12. Have an active systemic or local infection 13. Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control) 14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 15. Be concomitantly participating in another clinical study 16. Be involved in an injury claim under current litigation 17. Have a pending or approved worker’s compensation claim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rates is measured using the visual analog scale (VAS) (as defined by at least a 50% reduction in pain) at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful back pain relief is measured using the visual analog scale (VAS) at 1, 3, 6, 9 and 12 months 2. Percentage of patients who experience at least 50% reduction in pain intensity is measured using the VAS at 1, 3, 6, 9 and 12 months 3. Back pain intensity is measured using VAS at baseline, 1, 3, 6, 9 and 12 months 4. Percentage of participants who experience a back pain intensity score of =2.5 cm as measured using the VAS scale at 1, 3, 6, 9 and 12 months 5. Quality of life is measured using EQ-5D questionnaire at 3, 6 and 12 months 6. Health economic outcomes are measured using clinic visits, incidence of adverse events, EQ-5D at 1, 3, 6, 9 and 12 months | — |
Countries
Austria, Germany, Netherlands, United Kingdom
Contacts
Public ContactBrad Gliner
Outcome results
None listed