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

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.

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