Failed Back Surgery SyndromeNCT03761316
Goal Setting in SCS Patients: a Qualitative Review
An observational study of Failed Back Surgery Syndrome, run by Moens Maarten at 1 site in Belgium.
Trial summary
This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- interview regarding goals
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2018to 31 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Patients with medication-resistant chronic back and leg pain due to Failed Back Surgery Syndrome who are offered treatment with SCS.
Who may be able to join
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- FBSS patients suitable for SCS
- Age > 18 years
- Native Dutch or French speeking patients
Who cannot join
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (HIV positive, immunosuppressiva, etc.)
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- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal Setting in SCS Patients: a Qualitative Review (LEISURE)
This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- interview regarding goals
- Keywords
- Spinal cord stimulation, interview
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interview regarding goalsOther
interview regarding goals
| Study group | Role | What they receive |
|---|---|---|
| FBSS patients | patients with Failed Back Surgery Syndrome, eligible for SCS Receives: Other: interview regarding goals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goals and expectations towards spinal cord stimulation
Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview
Measured: Before spinal cord stimulation implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Dec 2018
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
- Investigators
- Maarten Moens, Prof. dr., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761316
- Sponsor's protocol ID
- LEISURE
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Setting in SCS Patients: a Qualitative Review (LEISURE)
- ClinicalTrials.gov ID
- NCT03761316
- Acronym / sponsor ID
- LEISURE
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Spinal cord stimulation, interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- 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 is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FBSS patients | – | Other: interview regarding goalspatients with Failed Back Surgery Syndrome, eligible for SCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with medication-resistant chronic back and leg pain due to Failed Back Surgery Syndrome who are offered treatment with SCS.
Key inclusion criteria (4 listed)
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- FBSS patients suitable for SCS
- Age > 18 years
- Native Dutch or French speeking patients
Key exclusion criteria (10 listed)
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
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 |
|---|---|---|
| interview regarding goalsinterview regarding goals | Other | FBSS patients |
Primary outcome
Goals and expectations towards spinal cord stimulation
Time frame: Before spinal cord stimulation implantation
Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Failed Back Surgery Syndrome
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SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
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Failed Back Surgery Syndrome
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.
Maarten Moens, Prof. dr. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome, run by Moens Maarten at 1 site in Belgium.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Goals and expectations towards spinal cord stimulation (time frame: Before spinal cord stimulation implantation). 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 17 Apr 2019.