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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain
• Intervention / Treatment: Other: CMM; Device: HF10 Therapy

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94065
      • NEVRO Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. 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

Key Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CMM; Conventional Medical Management	Other: CMM; Conventional Medical Management
Active Comparator: HF10 + CMM; Addition of HF10 therapy to CMM	Other: CMM; Conventional Medical Management; Device: HF10 Therapy; Senza 10 kHz Spinal Cord Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between treatment groups in responder rates.	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)	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disability as Measured by Oswestry Disability Index	Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score	6 months
Percentage change from baseline in back pain intensity (as assessed by VAS)		6 months
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire	It measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. In addition there is an EQ VAS which records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value".	6 months
Global impression of change	Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire	6 months
Change from baseline in opioid equivalent medication usage in each group		6 months
Neurological assessment	Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status.	3, 6 and 12 months
Incidences of adverse events		3, 6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)	Percentage change in back pain	24 months
Observational Outcomes on disability using Oswestry Disability Index scores	Percentage change from Baseline in ODI score	24 months
Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire	Change in quality of life index compared to baseline	24 months

Collaborators and Investigators

• Sponsor: Nevro Corp
• Investigators: Study Director: David Caraway, MD, NEVRO Corp

Publications and helpful links

General Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
• Patel N, Calodney A, Kapural L, Province-Azalde R, Lad SP, Pilitsis J, Wu C, Cherry T, Subbaroyan J, Gliner B, Caraway D. High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial. Pain Pract. 2021 Feb;21(2):171-183. doi: 10.1111/papr.12945. Epub 2020 Sep 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): October 6, 2020
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: CA2018-2 US NSRBP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes