Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
NCT ID: NCT02403518
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
45 participants
INTERVENTIONAL
2016-10-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Back Pain Only
Pain localized to the low back or buttocks.
Freedom Spinal Cord Stimulator System
Leg Pain Only
Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).
Freedom Spinal Cord Stimulator System
Back and Leg Pain
Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot).
Freedom Spinal Cord Stimulator System
Interventions
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Freedom Spinal Cord Stimulator System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Amphia ziekenhuis, Oosterhout, The Netherlands
UNKNOWN
Curonix LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Greg Jansen
Role: PRINCIPAL_INVESTIGATOR
Amphia ziekenhuis Oosterhout
Locations
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Amphia Ziekenhuis
Oosterhout, North Brabant, Netherlands
Countries
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Other Identifiers
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05-0071
Identifier Type: -
Identifier Source: org_study_id
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