Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-National, Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation Via the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain

Conditions
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Chronic Low Back Pain, Pain in Leg, Unspecified

Intervention / Treatment
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* Device: Freedom Spinal Cord Stimulator System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Back Pain Only<br>Pain localized to the low back or buttocks. | Device: Freedom Spinal Cord Stimulator System<br> <br> * Other names: Freedom-8A SCS System;|
| Active Comparator: Leg Pain Only<br>Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot). | Device: Freedom Spinal Cord Stimulator System<br> <br> * Other names: Freedom-8A SCS System;|
| Active Comparator: Back and Leg Pain<br>Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot). | Device: Freedom Spinal Cord Stimulator System<br> <br> * Other names: Freedom-8A SCS System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Self reported pain intensity measured by the Visual Analog Scale (VAS) | 12 months | 
| Incidence and severity of device related adverse events during the study. |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess compliance data to indicate usability of the device. | Questionnaire | 12 Months | 
| To assess the implanters' experience with the device. | Questionnaire | Average of 7 days after implant | 
| Patient satisfaction with treatment. | Questionnaire | 12 Months | 
| Reduced visits to health care institutes for chronic back and leg pain. | Questionnaire | 12 Months | 
| Improved work status. | Questionnaire | 12 Months | 
| Improved quality of life function via the ODI and EQ-5D questionnaires | ODI and EQ-5D Questionnaires | 12 Months | 
| Reduction in use of analgesics |  | 12 Months | 
| Reduced operating theater time | Review of hospital records | Average of 7 days after implant | 
| Reduced skin to skin time | Review of hospital records | Average of 7 days after implant | 
| Reduced skin to fluoroscope time | Review of hospital records | Average of 7 days after implant | 
| To monitor non-device and non-SCS-related adverse events |  | Up to 12 months |