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

NCT02403518 | Terminated

• 1 other identifier: 05-0071
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Pain in Leg, Unspecified

Outcome Measures

Primary Outcomes (2)

• 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.

  Self reported pain intensity measured by the Visual Analog Scale (VAS)

  12 months

• Incidence and severity of device related adverse events during the study.

  Up to 12 months

Secondary Outcomes (11)

• To assess compliance data to indicate usability of the device.

  12 Months

• To assess the implanters' experience with the device.

  Average of 7 days after implant

• Patient satisfaction with treatment.

  12 Months

• Reduced visits to health care institutes for chronic back and leg pain.

  12 Months

• Improved work status.

  12 Months

Study Arms (3)

Back Pain Only

ACTIVE COMPARATOR

Pain localized to the low back or buttocks.

Device: Freedom Spinal Cord Stimulator System

Leg Pain Only

ACTIVE COMPARATOR

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

Device: Freedom Spinal Cord Stimulator System

Back and Leg Pain

ACTIVE COMPARATOR

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

Device: Freedom Spinal Cord Stimulator System

Interventions

Freedom Spinal Cord Stimulator System DEVICE

Also known as: Freedom-4 SCS System, Freedom-4A SCS System, Freedom-8A SCS System

Back Pain Only; Back and Leg Pain; Leg Pain Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Appropriate Freedom SCS candidate as affirmed by study investigator
• Candidate has a stable spine not suitable for further surgery as confirmed by physician
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Curonix LLC: lead
• Amphia ziekenhuis, Oosterhout, The Netherlands: collaborator

Study Sites (1)

Amphia Ziekenhuis

Oosterhout, North Brabant, 4900, Netherlands

Location

Study Officials

• Greg Jansen

  Amphia ziekenhuis Oosterhout

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 31, 2015
• Study Start: October 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

NL (1)