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COMPLETED
NCT03680846
NA

Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

Sponsor: Nevro Corp

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2018-09-05

Completion Date

2022-05-09

Last Updated

2026-06-26

Healthy Volunteers

No

Conditions

Interventions

DEVICE

HF10 Therapy

Senza 10 kHz Spinal Cord Stimulation

OTHER

CMM

Conventional Medical Management

Locations (1)

Nevro Corp

Redwood City, California, United States