Abstract
BackgroundBotulinum neurotoxin (BoNT) is currently the best therapeutic option in the treatment for cervical dystonia (CD). Additional treatments like physiotherapy (PT) may even improve the results of the BoNT injection with type A (BoNT-A), but there are no definite recommendations. In the last few years, some studies showed tendencies for PT as an adjuvant therapy to benefit. However, high-quality studies are required.MethodsThis study is a multicentre, randomized, single-blind, controlled trial to demonstrate the effectiveness of a multimodal PT program compared to a nonspecific cupping therapy, additionally to the BoNT-A therapy. Two hundred participants will be assigned into the multimodal PT plus BoNT intervention arm or the BoNT plus cupping arm using randomization. Primary endpoint is the total Score of Toronto Western Spasmodic Rating Scale (TWSTRS). Secondary endpoints are the mobility of the cervical spine (range of motion, ROM), the TWSTRS subscales, and the quality of life (measured by questionnaires: CDQ-24 and SF-36). Patients will be single-blind assessed every 3 months according to their BoNT injection treatment over a period of 9 months.DiscussionThe study aims to determine the effectiveness and therefore potential benefit of an additional multimodal physiotherapy for standardized treatment with BoNT-A in patients with CD, towards the BoNT-therapy alone. This largest randomized controlled trial in this field to date is intended to generate missing evidence for therapy guidelines.Trial registrationThe study was registered in the German Clinical Study Register before the start of the patient recruitment (DRKS00020411; date: 21.01.2020).
Highlights
Background and rationale {6a} Cervical dystonia (CD) usually occurs as primary adult-onset dystonia between 30 and 50 years
The results showed that there were no significant differences between the different PT interventions, though both groups in each of these two studies showed improvements, especially in Toronto Western Spasmodic Rating Scale (TWSTRS) and generic quality of life after different add-on PT intervention [17, 18]
Secondary endpoints are the TWSTRS subscales, the range of motion (ROM) of the cervical spine assessed by threedimensional motion analysis using inertial sensors (Company: Velamed), the Short Form Health Survey (SF-36) questionnaire [23] to assess generic health perception, and the Craniocervical dystonia questionnaire – 24 (CDQ-24) questionnaire [24] to assess disease-specific quality of life
Summary
This study is a multicentre, randomized, single-blind, controlled trial to demonstrate the effectiveness of a multimodal PT program compared to a nonspecific cupping therapy, to the BoNT-A therapy. Two hundred participants will be assigned into the multimodal PT plus BoNT intervention arm or the BoNT plus cupping arm using randomization. Primary endpoint is the total Score of Toronto Western Spasmodic Rating Scale (TWSTRS). Secondary endpoints are the mobility of the cervical spine (range of motion, ROM), the TWSTRS subscales, and the quality of life (measured by questionnaires: CDQ-24 and SF-36). Patients will be single-blind assessed every 3 months according to their BoNT injection treatment over a period of 9 months
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