Goal Setting in SCS Patients: a Qualitative Review

Moens Maarten

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Other: interview regarding goals

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03761316

LEISURE

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

FBSS patients

Description:

patients with Failed Back Surgery Syndrome, eligible for SCS

Treatment:

Other: interview regarding goals