Multimodal physiotherapy as an add-on treatment to botulinum neurotoxin type A therapy in patients with cervical dystonia: a multicenter, single-blind, randomized, controlled study

Not Applicable

Recruiting

• Conditions: G24.3; Spasmodic torticollis

• Registration Number: DRKS00020411
• Lead Sponsor: eurologie Universitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

CD diagnosed classifiable with Col/Cap-classification (see also EC)
- Continuously treated with BoNT-A (Abobotulinumtoxin A) in three months interval (aiming to prevent bias by using different BoNT-A-products with different dosing strategies)
- At least 12 months treatment without relevant BoNT-A scheme changes over the last 3 injections

Exclusion Criteria

- CD with Antecollis/-caput only
- CD without dystonic symptom (only tremor)
- Contraindications for physiotherapy treatment
- Contraindications for BoNT-A treatment
- Refusal of study participation or simultaneous participation in other studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary object is the total Toronto Western Spasmodic Rating Scale (TWSTRS) score. <br><br>Evaluation will be carried out at the start and 3, 6 and 9 months later. Primary Outcome will be evaluated 6 months after the individual start (after the intervention).

Secondary Outcome Measures

Name	Time	Method
• TWSTRS severity, disability and pain scores<br>• Static and mobility of the cervical spine which will be detected by an ultrasonic based measuring system (ZEBRIS)<br>• SF-12 to evaluate the generic health and pain<br>• CDQ-24 to evaluate disease-specific quality of life<br><br>Measuring time points will be at the start and 3, 6 and 9 months later.