Goal Setting in SCS Patients: a Qualitative Review

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: interview regarding goals

• Registration Number: NCT03761316
• Lead Sponsor: Moens Maarten

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-30
• Study Start: 2018-12-01
• Study First Posted: 2018-12-03
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FBSS patients	interview regarding goals	patients with Failed Back Surgery Syndrome, eligible for SCS

Primary Outcome Measures

Name	Time	Method
Goals and expectations towards spinal cord stimulation	Before spinal cord stimulation implantation	Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium