KinesioTaping after botulinum toxin type A for cervical dystonia in adult patients

Abstract Introduction Studies explored physiotherapeutic approaches in cervical dystonia (CD) patients with or without botulinum toxin (BoNT) injections, however the results are varying. There are no clinical trials investigating the effects of kinesiology taping in CD patients. The objective of this study is to investigate the efficacy of kinesiology taping as an adjunct to the BoNT injections in patients with CD. Methods Twenty‐five patients were enrolled to the study. Patients were randomly assigned to the experimental 1 (BoNT + KinesioTaping), experimental 2 (BoNT + ShamTaping) or control (BoNT) treatment. After 12 weeks they were moved to the next experimental group and finally every patient received all 3 proposed treatment options. The severity of CD was quantified with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) including Torticollis severity, Disability, and Pain scales. Quality of life was evaluated using Craniocervical dystonia questionnaire (CDQ4). Results In all treatment groups, there was a significant improvement in dystonia symptoms measured with TWSTRS (total score) after BoNT injection regardless of the allocation to the experimental treatment (p < .05). ANOVA analysis revealed no differences in any of the TWSTRS variables after the intervention. Quality of life was significantly improved after application of taping (p < .05, p = .03). Conclusions Application of KinesioTaping after BoNT injection provided no additional effect on the severity of dystonia, although the quality of life was improved in patients with CD. Further research investigating the effect of KinesioTaping prior to BoNT injection is required.


INTRODUCTION
Cervical dystonia (CD), the most common form of adult-onset focal dystonia, is a movement disorder characterized by involuntary contractions of the cervical muscles due to a dysfunction of sensorimotor neural circuits. It causes twisting and repetitive movements of the neck and head and may be accompanied by tremor. Sometimes, CD results in abnormal postures (Albanese et al., 2015). Apart from motor symptoms, 36% of patients experience marked nonmotor symptoms such as psychiatric features (anxiety, depression, behavioral and cognitive problems), pain, sexual dysfunction or sleep impairment (Klingelhoefer et al., 2014). Seventy to ninety percent of patients develop the symptoms of CD between the age of 40 and 60 years. Females are twice more affected than males (Chan et al., 1991).
Motor and nonmotor symptoms of CD significantly impair daily functioning and cause embarrassment frequently leading to social withdrawal. Recent studies have shown a negative impact of CD on patients' quality of life (Ben-Shlomo et al., 2002;Muller et al., 2002;Pekmezovic et al., 2009;Van Den Dool et al., 2016).
CD treatment options offer inadequate effectiveness with scarce patient satisfaction. Chemodenervation with botulinum neurotoxin injection (BoNT) is a worldwide accepted standard of care for patients with CD. BoNT exerts its therapeutic effects by blocking neuromuscular acetylcholine transmission at the peripheral nerve terminals.
The therapeutic response becomes apparent within 1-2 weeks after the BoNT injection, with peak effects at approximately 4-6 weeks and a gradual decline in outcome thereafter (Albanese et al., 2011;Greene et al., 1990;Poewe et al., 1998;Poewe et al., 2016;Simpson et al., 2016). BoNT product guidelines currently recommend at least 12 weeks intervals between injections (http://www.ipsen.com; http://allergan-web-cdn-prod.azureedge.net). Thus, patients with CD treated with BoNT experience a rollercoaster effect, as they receive treatment with waning effectiveness over time that increases again following the subsequent injection (Francisco et al., 2021). Clearly, BoNT treatment meets a limited patient satisfaction. It seems meaningful to administer an adjunctive therapy that would maintain a near steadystate level of treatment outcome. For example, to enhance the effects of BoNT, physical therapy may be considered as a supplementary treatment (Crowner et al., 2007;Jankovic et al., 2006;Ressman et al., 2000;Smania et al., 2003;Tassorelli et al., 2006). Available studies explored rehabilitative approaches in CD patients with or without BoNT injections; however, the results are varying (Boyce et al., 2013;Counsell et al., 2016;De Pauw et al., 2014;Hu et al., 2019;Tassorelli et al., 2006).
Kinesiology taping, known as an alternative taping technique, involves a combination of tension applied along the tape and stretching of the target muscle. That, amongst others, results in a change of recruitment activity patterns of the muscles and alleviates prolonged muscle contraction and even postural deviation (Kase et al., 2016).
Kinesiology taping is currently used in rehabilitation of patients suffering from different neurological diseases. For instance, combining BoNT to the spastic equinovarus foot with kinesiotaping results in better outcome than applying sham taping (Karadag-Saygi et al., 2010;Kase et al., 2016). Low BoNT doses followed by ankle-foot taping is as effective as the injection of higher BoNT doses for the foot inversion with positive effects on gait parameters (Reiter et al., 1998).
To the best of our knowledge, there are no clinical trials investigating the effects of kinesiology taping on motor symptoms in CD patients.
The objective of this study is to investigate the efficacy of kinesiology taping as an adjunct to the BoNT injections in patients with CD.

Participants
The study was designed as a single-centre, prospective, evaluatorblind, randomized, crossover trial. Ethical approval was granted by the institutional review board.

Study design
Patients were randomly assigned to three groups with different therapeutic schemes: experimental 1 (BoNT + KinesioTaping), experimental 2 (BoNT + ShamTaping) or control (BoNT + no taping) treatment. After 12 weeks patients were moved to the next group and eventually every patient received all 3 proposed treatment options.
The randomization sequence was created using a computergenerated random number, with 1:1:1 allocation of individuals to either intervention groups or the control group. Subjects were assessed 2 times per cycle: at the BoNT injection visit and after 6 weeks. The randomization process and study design are summarized in Figure 1.
Outcome assessors and patients were unaware of treatment type, whilst the physiotherapist was informed on group assignments.

Procedures
Injections were performed every three months with the use of USG guidance. Muscles for BoNT injections were chosen individually accordingly to collum-caput (Col-Cap) concept subtype of CD; the scheme of BoNT injections and doses of BoNT were constant throughout the study (when subjects switched the experimental group, the scheme of injection and BoNT doses remained unchanged).

F I G U R E 1
The study design. Experimental groups: 1, experimental treatment 1 (BoNT+KinesioTaping); 2, experimental treatment 2 (BoNT + ShamTaping); 3, control (BoNT + no taping) Kinesiology taping was performed seven days after BoNT injection and for four consecutive weeks once per week by the same, experienced physiotherapist (see Figure 2). In the experimental group 1, patients were treated with the kinesiology tape using the dynamic In the experimental group 2, patients were taped, but in a nontherapeutic manner. The tape application was done without tension and without moving the head or neck, including stretching the muscles in the form of two vertical slices and one horizontal slice glued to the C-Th area of the spine.

RESULTS
Twenty-five patients diagnosed with primary CD were initially enrolled to the study, albeit there were six dropouts. The reasons for exclusion were: inability to attend taping caused by logistic complications (n = 2), unfinished second cycle of taping due to COVID-19 restrictions (n = 3), taping-related skin rash (n = 1). As a result, data from 19 patients were analyzed. The demographic and clinical features of patients are summarized in Table 1.

TWSTRS
In all treatment groups, there was a significant improvement in dys- ANOVA analysis revealed no differences in any of TWSTRS variables after the intervention (see Table 2). Figure 3 illustrates the changes in TWSTRS score calculated as a difference between TWSTRS score at the BoNT injection visit and TWSTRS score at the follow-up visit in the three experimental groups.

CDQ24
Quality of life was significantly improved from baseline after application of taping (p < .05 and p = .03). Considering individual domains of CDQ24, KinesioTaping improved "stigma" and "emotional wellbeing" after the intervention in experimental treatment group 1 (both p < .05). Whereas, in the ShamTaping group, "stigma" and F I G U R E 2 KinesioTaping (a-c). A patient with laterocaput on the right and torticaput on the left. (a) The assessment of fascial sliding over the semispinalis cervicis muscle. (b) The application of tape using the muscle technique. (c) Right splenius capitis muscle taped. The arrow shows direction of the tape impact on the fascia and the muscle. The tape application was made from deep to superficial muscles. The x mark indicates the base of the tape. ShamTaping (d and e). Application of two vertical (d) and one horizontal (e) slices without any tension and without moving the head or neck "activities of daily living" domains were markedly bettered (both p = .02; Table 3).
No side effects were observed following taping (except for one subject who experienced a skin rash after the first tape application), and patients reported positive feedback on treatment acceptability.

DISCUSSION
In this single-center, prospective, evaluator-blind, randomized, crossover study on the effect of KinesioTaping in patients with CD, we did not observe superior efficacy of taping as an adjunctive therapy to BoNT injection versus BoNT alone. Although no improvement was seen in the objective outcome measures, patients' quality of life evaluated using CDQ24, a patient-reported outcome, was ameliorated.
In other words, patients perceived a subjective improvement after treatment, however without outcome improvement when taping was applied. Dystonic movements in CD are caused by cocontraction of muscles that can be classified into three groups depending on their type of involvement: dystonic, antagonist, and compensatory. Muscles identified as responsible for pathological posture should be stretched and relaxed by the treatment procedure comprising BoNT injection and physiotherapy (Bleton et al., 2010;Tatu et al., 2007). KinesioTaping, which relies on applying tension along the tape and placing the target

Other features
Tremor "no-no" 7 (36.8%) Tremor "yes-yes" 2 (10.5% Abnormal sensorimotor cortical plasticity contributes to the pathophysiology of dystonia (Edwards et al., 2006;Quartarone et al., 2003). Kojovic et al. (2011) reported that BoNT injections into neck muscles decreased sensorimotor associative plasticity in the hand area in patients with CD. This central effect was mediated by changes in motor maps caused by reduced afferent input from neck muscles after the injections.
The blockade of neuromuscular acetylcholine transmission at the nerve terminals following BoNT injections results in a marked reduction of afferent input. This, in turn, stimulates reprogramming of central We acknowledge that this study had limitations such as a small sample size and the use of TWSTRS for rating dystonia severity. Accordingly, this research was designed to be evaluator-blind, randomized and crossover to overcome the weakness of a small number of patients participating in the study.
TWSTRS does not enable the evaluation of dystonic tremor that was present in some patients. What is more, TWSTRS does not weigh dystonic pattern according to the Col-Cap concept. The Col-Cal concept, established on the basis of CT/MRI imaging examination and functional anatomy, identifies eight major subtypes of CD (Finsterer et al., 2015;Reichel, 2011).
In summary, application of KinesioTaping after BoNT injection provided no effect on the severity of dystonia although it subjectively improved quality of life measures in patients with CD. We suspect that blockade on afferent nerve transmission induced by BoNT was responsible for reduced effect of KinesioTaping. Further research on a larger group of patients also investigating the effect of KinesioTaping prior to BoNT injection is required.