Goal Setting in SCS Patients: a Qualitative Review

Failed Back Surgery Syndrome Clinical Trial

Official title:

Goal Setting in SCS Patients: a Qualitative Review (LEISURE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761316
• Other study ID #: LEISURE
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Other:
• interview regarding goals
interview regarding goals

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Moens Maarten	Medtronic

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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