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

Primary Purpose

Chronic Low Back Pain, Pain in Leg, Unspecified

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Freedom Spinal Cord Stimulator System
Sponsored by
Stimwave Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Amphia Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Back Pain Only

Leg Pain Only

Back and Leg Pain

Arm Description

Pain localized to the low back or buttocks.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2015
Last Updated
October 20, 2020
Sponsor
Stimwave Technologies
Collaborators
Amphia ziekenhuis, Oosterhout, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT02403518
Brief Title
Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stimwave Technologies
Collaborators
Amphia ziekenhuis, Oosterhout, The Netherlands

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Pain in Leg, Unspecified

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Back Pain Only
Arm Type
Active Comparator
Arm Description
Pain localized to the low back or buttocks.
Arm Title
Leg Pain Only
Arm Type
Active Comparator
Arm Description
Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).
Arm Title
Back and Leg Pain
Arm Type
Active Comparator
Arm Description
Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot).
Intervention Type
Device
Intervention Name(s)
Freedom Spinal Cord Stimulator System
Other Intervention Name(s)
Freedom-4 SCS System, Freedom-4A SCS System, Freedom-8A SCS System
Primary Outcome Measure Information:
Title
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.
Description
Self reported pain intensity measured by the Visual Analog Scale (VAS)
Time Frame
12 months
Title
Incidence and severity of device related adverse events during the study.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
To assess compliance data to indicate usability of the device.
Description
Questionnaire
Time Frame
12 Months
Title
To assess the implanters' experience with the device.
Description
Questionnaire
Time Frame
Average of 7 days after implant
Title
Patient satisfaction with treatment.
Description
Questionnaire
Time Frame
12 Months
Title
Reduced visits to health care institutes for chronic back and leg pain.
Description
Questionnaire
Time Frame
12 Months
Title
Improved work status.
Description
Questionnaire
Time Frame
12 Months
Title
Improved quality of life function via the ODI and EQ-5D questionnaires
Description
ODI and EQ-5D Questionnaires
Time Frame
12 Months
Title
Reduction in use of analgesics
Time Frame
12 Months
Title
Reduced operating theater time
Description
Review of hospital records
Time Frame
Average of 7 days after implant
Title
Reduced skin to skin time
Description
Review of hospital records
Time Frame
Average of 7 days after implant
Title
Reduced skin to fluoroscope time
Description
Review of hospital records
Time Frame
Average of 7 days after implant
Title
To monitor non-device and non-SCS-related adverse events
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Jansen
Organizational Affiliation
Amphia ziekenhuis Oosterhout
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amphia Ziekenhuis
City
Oosterhout
State/Province
Noord-Brabant
ZIP/Postal Code
4900
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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