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

• ClinicalTrials.gov Identifier: NCT01609972
• Recruitment Status: Unknown
• First Posted: June 1, 2012
• Last Update Posted: July 2, 2015
• Sponsor: Nevro Corp
• Information provided by (Responsible Party): Nevro Corp

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Device: Spinal Cord Stimulator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2012
• Actual Primary Completion Date: May 2015
• Estimated Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test; Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System	Device: Spinal Cord Stimulator; Non-inferior comparison of implantable spinal cord stimulators
Active Comparator: Control; Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.	Device: Spinal Cord Stimulator; Non-inferior comparison of implantable spinal cord stimulators

Outcome Measures

Primary Outcome Measures :

1. Change in back pain VAS and neurological status from Baseline [ Time Frame: 3 months ]
   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 :

1. Change in disability as measured by Oswestry Disability Index [ Time Frame: 3, 6, 12 months ]
2. Number of subjects with adverse events [ Time Frame: 12 months ]

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Nevro Corp

Investigators

• Principal Investigator: Leonardo Kapural, MD; The Center for Clinical Research, Winston-Salem, NC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nevro Corp
• ClinicalTrials.gov Identifier: NCT01609972
• Other Study ID Numbers: CA2011 US
• First Posted: June 1, 2012
• Last Update Posted: July 2, 2015
• Last Verified: June 2015

Keywords provided by Nevro Corp:

Back pain; Spinal Cord Stimulation

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Chronic Pain; Pain; Neurologic Manifestations