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

Primary Purpose

Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HF10 Therapy

CMM

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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

Key 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

Sites / Locations

Nevro Corp

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

CMM

HF10 + CMM

Arm Description

Conventional Medical Management

Addition of HF10 therapy to CMM

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Percentage change from baseline in back pain intensity (as assessed by VAS)

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".

Global impression of change

Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire

Change from baseline in opioid equivalent medication usage in each group

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.

Incidences of adverse events

Full Information

NCT ID

NCT03680846

First Posted

November 14, 2017

Last Updated

October 7, 2021

Sponsor

Nevro Corp

1. Study Identification

Unique Protocol Identification Number

NCT03680846

Brief Title

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

Acronym

NSRBP

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

October 6, 2020 (Actual)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nevro Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CMM

Arm Type

Other

Arm Description

Conventional Medical Management

Arm Title

HF10 + CMM

Arm Type

Active Comparator

Arm Description

Addition of HF10 therapy to CMM

Intervention Type

Device

Intervention Name(s)

HF10 Therapy

Intervention Description

Senza 10 kHz Spinal Cord Stimulation

Intervention Type

Other

Intervention Name(s)

CMM

Intervention Description

Conventional Medical Management

Primary Outcome Measure Information:

Title

Difference between treatment groups in responder rates.

Description

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)

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

Change in Disability as Measured by Oswestry Disability Index

Description

Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score

Time Frame

6 months

Title

Percentage change from baseline in back pain intensity (as assessed by VAS)

Time Frame

6 months

Title

Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire

Description

Time Frame

6 months

Title

Global impression of change

Description

Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire

Time Frame

6 months

Title

Change from baseline in opioid equivalent medication usage in each group

Time Frame

6 months

Title

Neurological assessment

Description

Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status.

Time Frame

3, 6 and 12 months

Title

Incidences of adverse events

Time Frame

3, 6 and 12 months

Other Pre-specified Outcome Measures:

Title

Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)

Description

Percentage change in back pain

Time Frame

24 months

Title

Observational Outcomes on disability using Oswestry Disability Index scores

Description

Percentage change from Baseline in ODI score

Time Frame

24 months

Title

Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire

Description

Change in quality of life index compared to baseline

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key 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 Key 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Caraway, MD

Organizational Affiliation

Nevro Corp

Official's Role

Study Director

Facility Information:

Facility Name

Nevro Corp

City

Redwood City

State/Province

California

ZIP/Postal Code

94065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34854473

Citation

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.

Results Reference

derived

PubMed Identifier

33463027

Citation

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.

Results Reference

derived

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

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