chronic back and leg pain Failed back surgery syndrome
Conditions
Interventions
None listed
Sponsors
Clinical affairs
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Appropriate Freedom SCS candidate as affirmed by study investigator • Candidate has a stable spine not suitable for further surgery as confirmed by physician • 18 years of age or older (no upper age limit) • Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back • At least 6 months since last surgical procedure on the spine • Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain) • Pain duration of at least 6 months • Expected lifespan of at least two years • Able to comply with study requirements • Gives informed consent for study participation
Exclusion criteria
Exclusion criteria: • A consistent VAS score of 100 over the past 24 hours as established at Visit 1 • A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy) • Pregnant or planning to become pregnant • Known or suspected substance abuse within the last 2 years • Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion • Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events) • Documented allergy to Freedom SCS material components • Co-existing pain condition or participation in another clinical study that could confound the results of this study • History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes 1. Percentage of pain relief experienced in the area of pain identified at baseline compared to 12 months post full implant of the Freedom SCS system. 2. Incidence and severity of device related adverse events during the study, for example: a. Biological response to the implant procedure requiring treatment (e.g., hematoma, dural puncture, skin erosion or infection, allergic reaction) b. Technical failure of the electrode (e.g., electrode failure, fracture, or migration/malposition requiring removal/replacement) c. Technical failure of the external pulse generator (e.g., power level variations, over/under/intermittent /uncomfortable stimulation, unacceptable postural effects, device interaction with external stimulus). (Note: programming changes to increase paresthesia coverage to capture areas of new pain are not adverse events.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. To assess compliance data to indicate usability: o How many hours/day does the patient use the device? o Is this congruent with the clinician*s advice? o Is it sufficient to achieve the desired clinical result? 2. To assess the implanters* experience with the Freedom SCS system: o Technical difficulties or unforeseen problems during implantation o Implantation duration from skin incision to electrode entry 3. To determine additional beneficial effects such as: o Patient satisfaction with treatment o Reduced visits to health care institutes for chronic back and leg pain o Improved work status o Improved quality of life function via the ODI and EQ-5D questionnaires at 12 months compared to baseline o Reduction in use of analgesics o Reduced operating theater time, skin to skin time, and fluoroscope time 4. To monitor non-device and non-SCS-related adverse events (e.g., new disease states, unrelated death). | — |
Countries
Netherlands
Outcome results
None listed