Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain (PROSTIM)

Studie- & Opleidingscentrum Neurochirurgie Virga Jesse

Status: Unknown

Conditions: Chronic Pain; Failed Back Surgery Syndrome

Treatments: Device: Spinal cord stimulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05349695

001

Details and patient eligibility

About

The PROSTIM study is an ongoing prospective, multicentric and observational clinical study. Patients are recruited in three different centers in Eastern Belgium from May 2018 onwards. This real-world data collection approaches the outcome assessment of daily medical practice. A hierarchical cluster analysis is used to identify significant patient clusters based on the Visual Analogue Scale (VAS), Oswestry disability index (ODI), Pain Vigilance and Awareness Questionnaire (PVAQ), Pain Catastrophizing Scale (PCS) and EuroQol with five dimensions for health-related quality of life (EQ-5D). Patient clusters will be assessed on the change in biopsychosocial variables after six weeks, three and twelve months. Secondary outcomes include the comparison of pain medication use, SCS parameters, treatment satisfaction and return to work.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female over 18 years old.
• Chronic intractable back and/or leg pain (PSPS T2), refractory to conservative treatment measures.
• Positive recommendation after multidisciplinary assessment including psychiatric assessment.
• Patients are capable of giving written informed consent.

Exclusion criteria

• Negative recommendation after multidisciplinary assessment (ex. psychiatric disorders).
• Insufficient improvement during trial period.
• Previous SCS implantation.
• Removal due to complication (infection, loss of function,...)
• Surgical contraindication (infection of surgical site, coagulation disorders,..)
• Pregnancy.