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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
No Placebo-Only Group
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.
Eligible Conditions
- Back Pain
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference between treatment groups in responder rates.
Secondary study objectives
Change in Disability as Measured by Oswestry Disability Index
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
Global impression of change
+1 moreOther study objectives
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
8 Previous Clinical Trials
1,701 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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