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 Pain; Pain 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

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-31
• Study Start: 2016-10
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

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