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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Low Back Pain; Pain in Leg, Unspecified
• Intervention / Treatment: Device: Freedom Spinal Cord Stimulator System

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Oosterhout, Noord-Brabant, Netherlands, 4900
      • Amphia Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Back Pain Only; Pain localized to the low back or buttocks.	Device: Freedom Spinal Cord Stimulator System; Other Names: Freedom-4 SCS System; Freedom-4A SCS System; Freedom-8A SCS System
Active Comparator: Leg Pain Only; Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).	Device: Freedom Spinal Cord Stimulator System; Other Names: Freedom-4 SCS System; Freedom-4A SCS System; Freedom-8A SCS System
Active Comparator: Back and Leg Pain; Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot).	Device: Freedom Spinal Cord Stimulator System; Other Names: Freedom-4 SCS System; Freedom-4A SCS System; Freedom-8A SCS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess compliance data to indicate usability of the device.	Questionnaire	12 Months
To assess the implanters' experience with the device.	Questionnaire	Average of 7 days after implant
Patient satisfaction with treatment.	Questionnaire	12 Months
Reduced visits to health care institutes for chronic back and leg pain.	Questionnaire	12 Months
Improved work status.	Questionnaire	12 Months
Improved quality of life function via the ODI and EQ-5D questionnaires	ODI and EQ-5D Questionnaires	12 Months
Reduction in use of analgesics		12 Months
Reduced operating theater time	Review of hospital records	Average of 7 days after implant
Reduced skin to skin time	Review of hospital records	Average of 7 days after implant
Reduced skin to fluoroscope time	Review of hospital records	Average of 7 days after implant
To monitor non-device and non-SCS-related adverse events		Up to 12 months

Collaborators and Investigators

• Sponsor: Stimwave Technologies
• Collaborators: Amphia ziekenhuis, Oosterhout, The Netherlands
• Investigators: Principal Investigator: Greg Jansen, Amphia ziekenhuis Oosterhout

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 05-0071 (NIAID)