Clinical trial NCT05349695: Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
Official title: Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain: Study Protocol for a Prospective, Multicentric Observational Study (the PROSTIM Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Failed Back Surgery Syndrome
Chronic Pain
Keywords: Spinal cord stimulation
Patient profiling
Treatment pathways
Outcome assessment
Medial pathway
Lateral pathway
Descending pain modulation
Lead sponsor: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with chronic back and/or leg pain who have been approved by the multidisciplinary team for SCS treatment.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Back pain
timeFrame: 3 weeks
measure: Leg pain
timeFrame: 3 weeks
measure: Back pain
timeFrame: 6 months
measure: Leg pain
timeFrame: 6 months
measure: Back pain
timeFrame: 12 months
measure: Leg pain
timeFrame: 12 months
measure: Disability
timeFrame: 3 weeks
measure: Disability
timeFrame: 6 months
measure: Disability
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 3 weeks
measure: Health-related quality of life
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Pain medication
timeFrame: 3 weeks
measure: Pain medication
timeFrame: 6 months
measure: Pain medication
timeFrame: 12 months
measure: Spinal cord stimulation type
timeFrame: 3 weeks
measure: Spinal cord stimulation type
timeFrame: 6 months
measure: Spinal cord stimulation type
timeFrame: 12 months
measure: Satisfied with current treatment
timeFrame: 3 weeks
measure: Satisfied with current treatment
timeFrame: 6 months
measure: Satisfied with current treatment
timeFrame: 12 months
measure: Rate of return to work
timeFrame: 3 weeks
measure: Rate of return to work
timeFrame: 6 months
measure: Rate of return to work
timeFrame: 12 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Heusden-Zolder
country: Belgium
facility: Sint-Franciscus Ziekenhuis
city: Sint-Truiden
country: Belgium
facility: St. Trudo Ziekenhuis
Study officials:
affiliation: Jessa Hospital Hasselt, Belgium
name: Mark Plazier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: