Status:
UNKNOWN
Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
Lead Sponsor:
Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
Collaborating Sponsors:
Medtronic
Conditions:
Failed Back Surgery Syndrome
Chronic Pain
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05349695
Start Date
May 1 2022
End Date
May 1 2024
Last Update
April 27 2022
Active Locations (3)
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1
Jessa Hospital
Hasselt, Belgium
2
Sint-Franciscus Ziekenhuis
Heusden-Zolder, Belgium
3
St. Trudo Ziekenhuis
Sint-Truiden, Belgium