Chronic Low Back PainNCT02403518
Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
A study testing Freedom Spinal Cord Stimulator System in people with Chronic Low Back Pain and Pain in Leg, Unspecified, run by Curonix LLC at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Pain in Leg, Unspecified
- What is being tested?
- Freedom Spinal Cord Stimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Freedom Spinal Cord Stimulator System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom Spinal Cord Stimulator SystemDevice
Also called Freedom-4 SCS System, Freedom-4A SCS System, Freedom-8A SCS System
| Study group | Role | What they receive |
|---|---|---|
| Back Pain Only | Active comparator | Pain localized to the low back or buttocks. Receives: Device: Freedom Spinal Cord Stimulator System |
| Leg Pain Only | Active comparator | Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot). Receives: 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). Receives: Device: Freedom Spinal Cord Stimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Incidence and severity of device related adverse events during the study.
Measured: Up to 12 months
Secondary outcomes (11)
To assess compliance data to indicate usability of the device.
Questionnaire
Measured: 12 Months
To assess the implanters' experience with the device.
Questionnaire
Measured: Average of 7 days after implant
Patient satisfaction with treatment.
Questionnaire
Measured: 12 Months
Reduced visits to health care institutes for chronic back and leg pain.
Questionnaire
Measured: 12 Months
Improved work status.
Questionnaire
Measured: 12 Months
Improved quality of life function via the ODI and EQ-5D questionnaires
ODI and EQ-5D Questionnaires
Measured: 12 Months
Reduction in use of analgesics
Measured: 12 Months
Reduced operating theater time
Review of hospital records
Measured: Average of 7 days after implant
Reduced skin to skin time
Review of hospital records
Measured: Average of 7 days after implant
Reduced skin to fluoroscope time
Review of hospital records
Measured: Average of 7 days after implant
To monitor non-device and non-SCS-related adverse events
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startOct 2016
- Primary completionSep 2020
- Study completionSep 2020
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amphia ziekenhuis, Oosterhout, The Netherlands
- Responsible party
- Sponsor
- Investigators
- Greg Jansen, Principal investigator, Amphia ziekenhuis Oosterhout
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403518
- Sponsor's protocol ID
- 05-0071
- Status last verified
- Oct 2020
- First submitted
- 23 Mar 2015
- Last updated
- 22 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02403518
- Acronym / sponsor ID
- 05-0071
- Conditions
- Chronic Low Back Pain, Pain in Leg, Unspecified
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Collaborators
- Amphia ziekenhuis, Oosterhout, The Netherlands
- Study start
- Oct 2016
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Back Pain Only | Active comparator | Device: Freedom Spinal Cord Stimulator SystemPain localized to the low back or buttocks. |
| Leg Pain Only | Active comparator | Device: Freedom Spinal Cord Stimulator SystemPain localized to unilateral pain of the leg (thigh, knee, calf, or foot). |
| Back and Leg Pain | Active comparator | Device: Freedom Spinal Cord Stimulator SystemPain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freedom Spinal Cord Stimulator SystemAlso: Freedom-4 SCS System, Freedom-4A SCS System, Freedom-8A SCS System | Device | Back Pain Only, Back and Leg Pain, Leg Pain Only |
Primary outcome
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)
Incidence and severity of device related adverse events during the study.
Time frame: Up to 12 months
11 secondary outcomes
To assess compliance data to indicate usability of the device.
Time frame: 12 Months
To assess the implanters' experience with the device.
Time frame: Average of 7 days after implant
Patient satisfaction with treatment.
Time frame: 12 Months
Reduced visits to health care institutes for chronic back and leg pain.
Time frame: 12 Months
Improved work status.
Time frame: 12 Months
Improved quality of life function via the ODI and EQ-5D questionnaires
Time frame: 12 Months
Reduction in use of analgesics
Time frame: 12 Months
Reduced operating theater time
Time frame: Average of 7 days after implant
Reduced skin to skin time
Time frame: Average of 7 days after implant
Reduced skin to fluoroscope time
Time frame: Average of 7 days after implant
To monitor non-device and non-SCS-related adverse events
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Jansen principal investigator
Amphia ziekenhuis Oosterhout
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Spinal Cord Stimulator System in people with Chronic Low Back Pain and Pain in Leg, Unspecified, run by Curonix LLC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.