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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 12 months
Awards & highlights
NSRBP Trial Summary
This trial is testing a new, high-frequency spinal cord stimulator to see if it's more effective and has fewer side effects than traditional SCS devices, for people with chronic back pain who can't have surgery.
NSRBP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference between treatment groups in responder rates.
Secondary outcome measures
Change from baseline in opioid equivalent medication usage in each group
Change in Disability as Measured by Oswestry Disability Index
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
+4 moreOther outcome measures
Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire
Observational Outcomes on disability using Oswestry Disability Index scores
Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)
NSRBP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CMMExperimental Treatment1 Intervention
Conventional Medical Management
Group II: HF10 + CMMActive Control2 Interventions
Addition of HF10 therapy to CMM
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Who is running the clinical trial?
Nevro CorpLead Sponsor
7 Previous Clinical Trials
1,686 Total Patients Enrolled
1 Trials studying Back Pain
356 Patients Enrolled for Back Pain
David Caraway, MDStudy DirectorNevro Corp
5 Previous Clinical Trials
1,072 Total Patients Enrolled
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