Goal Setting in SCS Patients: a Qualitative Review | NCT03761316

Studies
Goal Setting in SCS Patients: a Qualitative Review

NCT03761316

Sponsor

Moens Maarten

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Failed Back Surgery Syndrome

Interventions

interview regarding goals

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Nov 28, 2018

First Submission Date that Met QC Criteria

Nov 30, 2018

First Posted Date

Dec 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FBSS patients		patients with Failed Back Surgery Syndrome, eligible for SCS	Other: interview regarding goals

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interview regarding goals	Other	interview regarding goals	FBSS patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Maarten Moens, Prof. dr.	Universitair Ziekenhuis Brussel	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel		Jette	Brussels Capital	1090	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D055111	Failed Back Surgery Syndrome

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain

Browse Leaves

Not provided

Browse Branches

Not provided