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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02403518
• Other study ID #: 05-0071
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2020

Study information

• Verified date: October 2020
• Source: Stimwave Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Low Back Pain
• Pain in Leg, Unspecified

Intervention

Device:
• Freedom Spinal Cord Stimulator System

Locations

Country	Name	City	State
Netherlands	Amphia Ziekenhuis	Oosterhout	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Stimwave Technologies	Amphia ziekenhuis, Oosterhout, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

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