Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
Not Applicable
Terminated
- Conditions
- Chronic Low Back PainPain in Leg, Unspecified
- Interventions
- Device: Freedom Spinal Cord Stimulator System
- Registration Number
- NCT02403518
- Lead Sponsor
- Curonix LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Back Pain Only Freedom Spinal Cord Stimulator System Pain localized to the low back or buttocks. Back and Leg Pain Freedom Spinal Cord Stimulator System Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot). Leg Pain Only Freedom Spinal Cord Stimulator System Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Reduced skin to fluoroscope time Average of 7 days after implant Review of hospital records
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
Improved quality of life function via the ODI and EQ-5D questionnaires 12 Months ODI and EQ-5D Questionnaires
Reduced skin to skin 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
Reduction in use of analgesics 12 Months Reduced operating theater time Average of 7 days after implant Review of hospital records
Trial Locations
- Locations (1)
Amphia Ziekenhuis
🇳🇱Oosterhout, Noord-Brabant, Netherlands