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

Nevro

Status

Unknown

Conditions

Chronic Low Back Pain

Treatments

Device: Spinal Cord Stimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01609972

CA2011 US

Details and patient eligibility

About

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.

Enrollment

356 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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