The BIRD study. Intrathecal Baclofen Infusion for Reflex Sympathetic Dystrophy related dystonia.

Completed

• Conditions: Reflex sympathetic dystrophy (RSD) related dystonia.

• Registration Number: NL-OMON27484
• Lead Sponsor: eiden University Medical Centre, Dept. of Neurology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1. All patients should fulfill the diagnostic criteria of the complex regional pain syndrome consensus report of the International Association for the Study of Pain (IASP):

a. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event;

Exclusion Criteria

N/A

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. GDS will be calculated separately at baseline (GDShome) and during a week at 1 year of follow-up. The difference between these two measurements is identified as the change from baseline in GDS at 1-year follow-up (GDS1year); <br /><br>2. Dystonia related functional limitations (DFL) are self-assessed at hourly intervals across the day using 4 items, addressing upper extremity function, capability of making transfers and mobility. Each item is assessed on a 0 – 3 scale. DFL will be calculated at baseline (DFLhome) and during a week at 1 year of follow-up. <br />The difference between these 2 measurements is identified as the change from baseline in DFL at 1 year follow-up (DFL1year).

Secondary Outcome Measures

Name	Time	Method
1. RSD related impairments; <br /><br>2. ADL and quality of life will be assessed separately before implantation and at 1-year follow-up; <br /><br>3. The difference between these 2 measurements is identified as the change from baseline for each score.