Chronic Low Back Pain, Pain in Leg, Unspecified
Conditions
Brief summary
This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome (FBSS) will receive a stimulator device for treatment of their pain.
Interventions
DEVICEFreedom Spinal Cord Stimulator System
Sponsors
Amphia ziekenhuis, Oosterhout, The Netherlands
Curonix LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| 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. | 12 months | Self reported pain intensity measured by the Visual Analog Scale (VAS) |
| Incidence and severity of device related adverse events during the study. | Up to 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in use of analgesics | 12 Months | — |
| To assess compliance data to indicate usability of the device. | 12 Months | Questionnaire |
| To assess the implanters' experience with the device. | Average of 7 days after implant | Questionnaire |
| Patient satisfaction with treatment. | 12 Months | Questionnaire |
| Improved work status. | 12 Months | Questionnaire |
| Reduced operating theater time | Average of 7 days after implant | Review of hospital records |
| Reduced skin to skin time | Average of 7 days after implant | Review of hospital records |
| Reduced skin to fluoroscope time | Average of 7 days after implant | Review of hospital records |
| To monitor non-device and non-SCS-related adverse events | Up to 12 months | — |
| Reduced visits to health care institutes for chronic back and leg pain. | 12 Months | Questionnaire |
| Improved quality of life function via the ODI and EQ-5D questionnaires | 12 Months | ODI and EQ-5D Questionnaires |
Countries
Netherlands
Outcome results
None listed