A clinical study to investigate the preference of new programming settings with the Nevro Senza Spinal Cord Stimulation system
- Conditions
- Failed Back Surgery Syndrome (FBSS)Nervous System Diseases
- Registration Number
- ISRCTN54708653
- Lead Sponsor
- evro Corp
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34601597/ (added 25/03/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 31
1. Have been diagnosed with chronic, intractable pain of the back pain with or without leg pain secondary to Failed Back Surgery Syndrome (FBSS)
2. Have been implanted with the Nevro Senza SCS system with dual leads, approximately over vertebral T8-T11, for at least 3 months, and are using the system with single area, continuous 10 kHz stimulation programs at least 18 hours daily, as determined by subject reporting and confirmation via device diagnostics, for at least 21 days prior to enrolling in this study
3. If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first
4. Be 18 years of age or older at the time of enrollment
5. Be willing and able to comply with study-related requirements, procedures, and visits
6. Be capable of subjective evaluation, able to read and understand ethics committee (EC) approved written questionnaires, and are able to read, understand and sign the EC approved written informed consent, all of which will be in Australian English
7. Be compliant in using the patient programmer and recharger as determined by the Investigator
8. As determined by the Investigator, be compliant in adjusting programs using the device remote control
9. Considering daily activity and rest, report a recall average back pain relief of > 50% compared with pre-implant and a recall average NRS score for back pain of <5 during the previous 14 days prior to study enrollment
1. Have 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, as determined by the Investigator
2. Have 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
3. Have 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, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator
4. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention
5. Having undergone an interventional procedure and/or surgery to treat back or leg pain other than Senza HF10 therapy in the last 30 days
6. Have a condition currently requiring or likely to require diathermy
7. Have a condition currently requiring or likely to require surgery during the study period.
8. Have metastatic malignant disease or active local malignant disease
9. Have a life expectancy of less than 1 year
10. Have an active systemic or local infection
11. Be pregnant or planning to become pregnant during the course of the study (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)
12. 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)
13. Be concomitantly participating or planned to be participating in another clinical study overlapping in time with the present clinical study
14. Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other non-Senza SCS devices
15. Have an unresolved condition of device-related pain (e.g. IPG pocket pain)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects expressing preference for any <100%DC stimulator program [Treatment] or no preference, versus preference for the 100%DC stimulator program [Control] for all subjects successfully completing the end of other duty cycle assessments phase using Senza SCS HF10 therapy is measured using the Preference Questionnaire at 3 and 5 weeks.
- Secondary Outcome Measures
Name Time Method <br> 1. Back pain intensity is determined using Numerical Rating Scale (NRS) values as assessed using the participant's pain diary at baseline, 3, 5 and 17 weeks<br> 2. Leg pain intensity is determined using Numerical Rating Scale (NRS) values as assessed using the participant's pain diary at baseline, 3, 5 and 17 weeks<br> 3. Patient's Global Impression of change at 17 weeks<br> 4. Clinician's Global Impression of change at 17 weeks<br> 5. Adverse events are measured through self-reporting at all study visits (scheduled and unscheduled)<br> 6. Subject satisfaction measured by the Subject Satisfaction questionnaire (questionnaire is specifically designed for this study) at 17 weeks<br>