The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1

The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1 - ITB flow rate study in CRPS I

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31522

Enrollment

Registered

2008-02-18

Start date

2008-04-17

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

dystonia of enlarged muscletone

Interventions

Intrathecal baclofen administered using a baseline flow rate (concentration 3000 microgr/ml) or 4 times higher (concentration 750 microgr/ml).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Patients must suffer from tonic or intermittent dystonia in one or more extremities. •Patients have an implanted programmable pump (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) for continuous intrathecal drug administration. •Patients have shown an insufficient response to intrathecal baclofen (ITB) at the usual flow rate, that is a

Exclusion criteria

Exclusion criteria: Exclusion criteria are other causes of dystonia and pregnancy

Design outcomes

Primary

Measure	Time frame
Primary outcomes are severity of pain and dystonia using a NRS.	—

Secondary

Measure	Time frame
1. Efficacy as evaluated by dystonia severity (Burke-Fahn-Marsden scale), patient*s preference (PPQ), and global impression of improvement after each treatment (global impression scale). 2. Safety of the procedure as evaluated by the occurrence of adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)