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

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ClinicalTrials.gov Identifier: NCT02403518
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Amphia ziekenhuis, Oosterhout, The Netherlands
Information provided by (Responsible Party):
Stimwave Technologies

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Pain in Leg, Unspecified Device: Freedom Spinal Cord Stimulator System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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




Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
    Self reported pain intensity measured by the Visual Analog Scale (VAS)

  2. Incidence and severity of device related adverse events during the study. [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. To assess compliance data to indicate usability of the device. [ Time Frame: 12 Months ]
    Questionnaire

  2. To assess the implanters' experience with the device. [ Time Frame: Average of 7 days after implant ]
    Questionnaire

  3. Patient satisfaction with treatment. [ Time Frame: 12 Months ]
    Questionnaire

  4. Reduced visits to health care institutes for chronic back and leg pain. [ Time Frame: 12 Months ]
    Questionnaire

  5. Improved work status. [ Time Frame: 12 Months ]
    Questionnaire

  6. Improved quality of life function via the ODI and EQ-5D questionnaires [ Time Frame: 12 Months ]
    ODI and EQ-5D Questionnaires

  7. Reduction in use of analgesics [ Time Frame: 12 Months ]
  8. Reduced operating theater time [ Time Frame: Average of 7 days after implant ]
    Review of hospital records

  9. Reduced skin to skin time [ Time Frame: Average of 7 days after implant ]
    Review of hospital records

  10. Reduced skin to fluoroscope time [ Time Frame: Average of 7 days after implant ]
    Review of hospital records

  11. To monitor non-device and non-SCS-related adverse events [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403518


Contacts
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Contact: Niek Vanquathem 0032 492 69 22 23 niek@freedomneuro.com

Locations
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Netherlands
Amphia Ziekenhuis Recruiting
Oosterhout, Noord-Brabant, Netherlands, 4900
Contact: Juliette Mouws       JMouws@Amphia.nl   
Principal Investigator: Greg Jansen         
Sponsors and Collaborators
Stimwave Technologies
Amphia ziekenhuis, Oosterhout, The Netherlands
Investigators
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Principal Investigator: Greg Jansen Amphia ziekenhuis Oosterhout

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Responsible Party: Stimwave Technologies
ClinicalTrials.gov Identifier: NCT02403518     History of Changes
Other Study ID Numbers: 05-0071
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms