A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain

Nevro Corp1 site in 1 country211 target enrollmentSeptember 5, 2018

ConditionsBack Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Back Pain
Sponsor: Nevro Corp
Enrollment: 211
Locations: 1
Primary Endpoint: Difference between treatment groups in responder rates.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.

Registry

clinicaltrials.gov

Start Date

September 5, 2018

End Date

November 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nevro Corp

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
•Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
•Qualifying pain score
•Be on stable pain medications, as determined by the Investigator
•Be willing and capable of giving informed consent
•Be willing and able to comply with study-related requirements, procedures, and visits
•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

•Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
•Have a medical condition or pain in other area(s), not intended to be treated in this study
•Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
•Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
•Have any addictions as determined by the Investigator
•Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
•Have prior experience with neuromodulation devices
•Other general exclusions applicable for SCS devices
•Be involved in an injury claim under current litigation
•Have a pending or approved worker's compensation claim

Outcomes

Primary Outcomes

Difference between treatment groups in responder rates.

Time Frame: 3 Months

Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS)

Secondary Outcomes

Percentage change from baseline in back pain intensity (as assessed by VAS)(6 months)
Change from baseline in opioid equivalent medication usage in each group(6 months)
Change in Disability as Measured by Oswestry Disability Index(6 months)
Neurological assessment(3, 6 and 12 months)
Global impression of change(6 months)
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire(6 months)
Incidences of adverse events(3, 6 and 12 months)