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

NCT01609972 | Unknown DMC

• 1 other identifier: CA2011 US
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Keywords

Back pain; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Change in disability as measured by Oswestry Disability Index

  3, 6, 12 months

• Number of subjects with adverse events

  12 months

Study Arms (2)

Test

EXPERIMENTAL

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

Device: Spinal Cord Stimulator

Control

ACTIVE COMPARATOR

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

Device: Spinal Cord Stimulator

Interventions

Spinal Cord Stimulator DEVICE

Non-inferior comparison of implantable spinal cord stimulators

Control; Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevro Corp: lead

Related Publications (1)

• 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.

  PMID: 29858746 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonardo Kapural, MD

  The Center for Clinical Research, Winston-Salem, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-06