Goal Setting in SCS Patients: a Qualitative Review
Overview
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.
Full Title of Study: “Goal Setting in SCS Patients: a Qualitative Review (LEISURE)”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: January 31, 2019
Interventions
- Other: interview regarding goals
- interview regarding goals
Arms, Groups and Cohorts
- FBSS patients
- patients with Failed Back Surgery Syndrome, eligible for SCS
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
Inclusion Criteria
- 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 Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Moens Maarten
- Collaborator
- Medtronic
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Moens Maarten, Prof. dr. – Universitair Ziekenhuis Brussel
- Overall Official(s)
- Maarten Moens, Prof. dr., Principal Investigator, Universitair Ziekenhuis Brussel
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