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

Last updated: April 22, 2022
Sponsor: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT05349695
001
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Negative recommendation after multidisciplinary assessment (ex. psychiatricdisorders).
  • 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.

Study Design

Total Participants: 200
Study Start date:
May 01, 2022
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Jessa Hospital

    Hasselt,
    Belgium

    Active - Recruiting

  • Sint-Franciscus Ziekenhuis

    Heusden-Zolder,
    Belgium

    Active - Recruiting

  • St. Trudo Ziekenhuis

    Sint-Truiden,
    Belgium

    Active - Recruiting

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