Goal Setting in SCS Patients: a Qualitative Review

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Other: interview regarding goals

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with medication-resistant chronic back and leg pain due to Failed Back Surgery Syndrome who are offered treatment with SCS.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FBSS patients; patients with Failed Back Surgery Syndrome, eligible for SCS	Other: interview regarding goals; interview regarding goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Moens Maarten
• Collaborators: Medtronic
• Investigators: Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Spinal cord stimulation; interview
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: LEISURE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No