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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