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

Curonix

Status: Terminated

Conditions: Chronic Low Back Pain; Pain in Leg, Unspecified

Treatments: Device: Freedom Spinal Cord Stimulator System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02403518

05-0071 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Back Pain Only

Active Comparator group

Description:

Pain localized to the low back or buttocks.

Treatment:

Device: Freedom Spinal Cord Stimulator System

Leg Pain Only

Active Comparator group

Description:

Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).

Treatment:

Device: Freedom Spinal Cord Stimulator System

Back and Leg Pain

Active Comparator group

Description:

Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot).

Treatment:

Device: Freedom Spinal Cord Stimulator System