Clinical trial NCT02403518: Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low Back Pain
Pain in Leg, Unspecified
Lead sponsor: Curonix LLC
Sponsor class: INDUSTRY
Collaborators: name: Amphia ziekenhuis, Oosterhout, The Netherlands
First posted: 2015-03-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

* 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)

Primary outcomes:
measure: 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.
timeFrame: 12 months
measure: Incidence and severity of device related adverse events during the study.
timeFrame: Up to 12 months
Secondary outcomes:
measure: To assess compliance data to indicate usability of the device.
timeFrame: 12 Months
measure: To assess the implanters' experience with the device.
timeFrame: Average of 7 days after implant
measure: Patient satisfaction with treatment.
timeFrame: 12 Months
measure: Reduced visits to health care institutes for chronic back and leg pain.
timeFrame: 12 Months
measure: Improved work status.
timeFrame: 12 Months
measure: Improved quality of life function via the ODI and EQ-5D questionnaires
timeFrame: 12 Months
measure: Reduction in use of analgesics
timeFrame: 12 Months
measure: Reduced operating theater time
timeFrame: Average of 7 days after implant
measure: Reduced skin to skin time
timeFrame: Average of 7 days after implant
measure: Reduced skin to fluoroscope time
timeFrame: Average of 7 days after implant
measure: To monitor non-device and non-SCS-related adverse events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Oosterhout
country: Netherlands
facility: Amphia Ziekenhuis
state: Noord-Brabant
Study officials:
affiliation: Amphia ziekenhuis Oosterhout
name: Greg Jansen
role: PRINCIPAL_INVESTIGATOR
References: