Goal Setting in SCS Patients: a Qualitative Review
1 other identifier
observational
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedApril 17, 2019
April 1, 2019
2 months
November 28, 2018
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Goals and expectations towards spinal cord stimulation
Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview
Before spinal cord stimulation implantation
Study Arms (1)
FBSS patients
patients with Failed Back Surgery Syndrome, eligible for SCS
Interventions
Eligibility Criteria
Patients with medication-resistant chronic back and leg pain due to Failed Back Surgery Syndrome who are offered treatment with SCS.
You may qualify if:
- 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
You may not qualify if:
- 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.)
- Life expectancy \< 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
- Medtroniccollaborator
Study Sites (1)
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Moens, Prof. dr.
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. dr.
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 3, 2018
Study Start
December 1, 2018
Primary Completion
January 31, 2019
Study Completion
March 31, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04