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Completed

NCT Number: NCT03761316

Goal Setting in SCS Patients: a Qualitative Review

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview regarding goals

Other

interview regarding goals

Primary outcomes

  1. Goals and expectations towards spinal cord stimulation

    Time frame: Before spinal cord stimulation implantation

    Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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