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Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain (SENZA-RCT)

Primary Purpose

Chronic Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Spinal Cord Stimulator

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Back pain, Spinal Cord Stimulation

Eligibility Criteria

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

Inclusion Criteria:

Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be 18 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
Have a diagnosis of scoliosis that precludes lead placement
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
Have prior experience with SCS
Have a condition currently requiring or likely to require the use of MRI or diathermy
Have metastatic malignant disease or active local malignant disease
Have a life expectancy of less than 1 year
Have an active systemic or local infection
Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
Be concomitantly participating in another clinical study
Be involved in an injury claim under current litigation
Have a pending or approved worker's compensation claim

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Control

Arm Description

Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System

Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.

Outcomes

Primary Outcome Measures

Change in back pain VAS and neurological status from Baseline

The primary endpoint is a composite of effectiveness and safety. Specifically, the primary endpoint is the percentage of randomized subjects (the ITT analysis population) and subjects completing the Primary Efficacy Assessment (the PP analysis population) who respond to SCS therapy (as assessed by VAS) for back pain and do not have a stimulation-related neurological deficit at the Primary Efficacy Assessment (non-inferiority analysis). Subjects who do not have a successful Trial Phase are considered failures (non-responders) toward the primary endpoint.

Secondary Outcome Measures

Change in disability as measured by Oswestry Disability Index

Number of subjects with adverse events

Full Information

NCT ID

NCT01609972

First Posted

May 30, 2012

Last Updated

June 30, 2015

Sponsor

Nevro Corp

1. Study Identification

Unique Protocol Identification Number

NCT01609972

Brief Title

Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

Acronym

SENZA-RCT

Official Title

Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain as Compared to Commercially Available SCS Devices

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nevro Corp

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.

6. Conditions and Keywords

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

Chronic Low Back Pain

Keywords

Back pain, Spinal Cord Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

356 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test

Arm Type

Experimental

Arm Description

Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.

Intervention Type

Device

Intervention Name(s)

Spinal Cord Stimulator

Intervention Description

Non-inferior comparison of implantable spinal cord stimulators

Primary Outcome Measure Information:

Title

Change in back pain VAS and neurological status from Baseline

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in disability as measured by Oswestry Disability Index

Time Frame

3, 6, 12 months

Title

Number of subjects with adverse events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician Be 18 years of age or older at the time of enrollment Be willing and capable of giving informed consent Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus Have a diagnosis of scoliosis that precludes lead placement Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker Have prior experience with SCS Have a condition currently requiring or likely to require the use of MRI or diathermy Have metastatic malignant disease or active local malignant disease Have a life expectancy of less than 1 year Have an active systemic or local infection Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) Be concomitantly participating in another clinical study 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

Leonardo Kapural, MD

Organizational Affiliation

The Center for Clinical Research, Winston-Salem, NC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

29858746

Citation

Amirdelfan K, Yu C, Doust MW, Gliner BE, Morgan DM, Kapural L, Vallejo R, Sitzman BT, Yearwood TL, Bundschu R, Yang T, Benyamin R, Burgher AH, Brooks ES, Powell AA, Subbaroyan J. Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT. Qual Life Res. 2018 Aug;27(8):2035-2044. doi: 10.1007/s11136-018-1890-8. Epub 2018 Jun 1.

Results Reference

derived

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Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

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