Application observation regarding the dose change of the intrathecally required antispastic drug baclofen via a pump system and the occurrence of postoperative complications in the context of intrathecal baclofen therapy (ITB) in paraplegic patients at the BG Klinikum Hamburg in the period from 1991 to 2021.
- Conditions
- paralysis-related spasticity in para- & tetraplegics
- Registration Number
- DRKS00031760
- Lead Sponsor
- BG Klinikum Hamburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
Severe spastic syndrome not compatible with life for the patient
- Insufficient effect of oral antispastic therapy
- Significant improvement of spasticity after intrathecal trial injection of baclofen
Exclusion Criteria
not applicable
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the data evaluation is to analyze the efficacy and safety of intrathecal baclofen (ITB) therapy, with the primary question comparing the intrathecal primary daily dose, a value within the first six months postoperatively, with the intrathecal maintenance dose, a value in the time corridor between 13 to 17 years postoperatively.<br>
- Secondary Outcome Measures
Name Time Method Secondary, especially with regard to the safety and problems in the application of this therapy, the focus should be on the occurring postoperative complications.<br><br>