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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031760

Enrollment

Registered

2023-04-26

Start date

2021-10-25

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paralysis-related spasticity in para- & tetraplegics

Interventions

Group 1: Intrathecal baclofen therapy (ITB) in paraplegic patients.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: not applicable

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary, especially with regard to the safety and problems in the application of this therapy, the focus should be on the occurring postoperative complications.	—

Countries

Germany

Contacts

Public ContactRoland Thietje

BG Klinikum Hamburg

r.thietje@bgk-hamburg.de+494073062601

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026