Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial (Panorama)

Saluda Medical

Status

Completed

Conditions

Chronic Pain

Treatments

Device: Saluda Medical External Trial System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02161627

SBWSH1302

U1111-1157-5143 (Other Identifier)

Details and patient eligibility

About

The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs

Full description

Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients enrolled in this study must meet the following 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.
Have been approved to undergo a trial of SCS.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
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
Females of childbearing age must have a negative urine pregnancy test at baseline

Exclusion criteria

Patients enrolled in this study must not meet the following 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 outcomes
Are not a surgical candidate due to a 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 a condition, treatable with SCS, that requires leads to be inserted into the cervical region
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
Have a condition currently requiring or likely to require the use of MRI or diathermy
Have pain due to a malignant disease
Have a life expectancy of less than 1 year
Have an active systemic or local infection
Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
Be pregnant or nursing (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/or 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