Effectiveness of Kinesio taping on peripheral facial paralysis: A protocol for systematic review and meta-analysis

Abstract

Background:
Peripheral facial paralysis is a rapid unilateral facial paralysis or paralysis of unknown etiology. Nearly 30% of patients leave sequela that have a negative impact on the patient's quality of life, both physically and psychologically. As its safety, convenience and effectiveness, Kinesio taping has been gradually used in the rehabilitation of peripheral facial paralysis. However, whether Kinesio taping is effective for peripheral facial paralysis is still unknown. The purpose of this systematic review (SR) and meta-analysis will summarize the current evidence of Kinesio taping used as an intervention for peripheral facial paralysis.

Methods and analysis:
We will search the following electronic databases for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) to evaluate the effectiveness of Kinesio taping in treating peripheral facial paralysis: China National Knowledge Infrastructure (CNKI), Wanfang Date, SinoMed, Technology Periodical Database (VIP), PubMed, Embase, Web of Science, and The Cochrane Library. Each database will be searched from inception to April 2020. Studies that present clear descriptions of Kinesio taping in treating peripheral facial paralysis administration are published in peer-reviewed journals in any languages and are published in full will be taken into consideration. The entire process will include study selection, data extraction, risk of bias assessment and meta-analyses. Assessment of risk of bias and data synthesis will be conducted using Review Manager 5.3 software.

Results:
The current evidence on the Kinesio taping for managing peripheral facial paralysis will be illustrated using subjective reports and objective measures of performance. The primary outcome is the effective rate. Secondary outcomes include House-Brackmann scale, Portmann score, facial nerve conduction velocity, Facial Disability Index, Facial Disability Index include Facial Function score and social Function score.

Conclusion:
This protocol will present evidence on the efficacy of Kinesio taping in relieving peripheral facial paralysis.

Ethics and dissemination:
Since all the data used in this SR and meta-analysis have been published, ethical approval is not required for this review. The results of this SR will be published in a peer-reviewed journal or presented at conferences. INPLASY ID:: (INPLASY2020100008).

Full text

Effectiveness of Kinesio taping on peripheral
facial paralysis
A protocol for systematic review and meta-analysis
Zai-hui Sun, BD
a
, Yan-ping Tian, BD
a
, Yan-fu Tan, BD
a
, Dan Tao, BD
a
, Wen-bo Li, BD
b
, Ji-lin Ding, BD
c
,
Shuang-chun Ai, MD
c,∗
Abstract
Background: Peripheral facial paralysis is a rapid unilateral facial paralysis or paralysis of unknown etiology. Nearly 30% of patients
leave sequela that have a negative impact on the patient’s quality of life, both physically and psychologically. As its safety,
convenience and effectiveness, Kinesio taping has been gradually used in the rehabilitation of peripheral facial paralysis. However,
whether Kinesio taping is effective for peripheral facial paralysis is still unknown. The purpose of this systematic review (SR) and meta-
analysis will summarize the current evidence of Kinesio taping used as an intervention for peripheral facial paralysis.
Methods and analysis: We will search the following electronic databases for randomized controlled trials (RCTs) and controlled
clinical trials (CCTs) to evaluate the effectiveness of Kinesio taping in treating peripheral facial paralysis: China National Knowledge
Infrastructure (CNKI), Wanfang Date, SinoMed, Technology Periodical Database (VIP), PubMed, Embase, Web of Science, and The
Cochrane Library. Each database will be searched from inception to April 2020. Studies that present clear descriptions of Kinesio
taping in treating peripheral facial paralysis administration are published in peer-reviewed journals in any languages and are published
in full will be taken into consideration. The entire process will include study selection, data extraction, risk of bias assessment and
meta-analyses. Assessment of risk of bias and data synthesis will be conducted using Review Manager 5.3 software.
Results: The current evidence on the Kinesio taping for managing peripheral facial paralysis will be illustrated using subjective
reports and objective measures of performance. The primary outcome is the effective rate. Secondary outcomes include House-
Brackmann scale, Portmann score, facial nerve conduction velocity, Facial Disability Index, Facial Disability Index include Facial
Function score and social Function score.
Conclusion: This protocol will present evidence on the efficacy of Kinesio taping in relieving peripheral facial paralysis.
Ethics and dissemination: Since all the data used in this SR and meta-analysis have been published, ethical approval is not
required for this review. The results of this SR will be published in a peer-reviewed journal or presented at conferences.
INPLASY ID: (INPLASY2020100008).
Abbreviations: CCTs =controlled clinical trials, RCTs =randomized controlled trials, SR =systematic review.
Keywords: Kinesio taping, meta-analysis, peripheral facial paralysis, protocol, systematic review
This study was supported by Chengdu University of Traditional Chinese Medicine 2019 Xinglin Scholar Hospital Special Project (YYZX2019015).
The authors have no conflicts of interest to disclose.
Supplemental Digital Content is available for this article.
The datasets generated during and/or analyzed during the current study are publicly available.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
a
School of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine,
b
Eye College of Chengdu University of Traditional Chinese
Medicine,
c
Mianyang Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Sichuan, China.
∗
Correspondence: Shuang-chun Ai, Mianyang Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Sichuan, China
(e-mail: aishuangchun@163.com).
Copyright ©2020 the Author(s). Published by Wolters Kluwer Health, Inc.
This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
How to cite this article: Sun Zh, Tian Yp, Tan Yf, Tao D, Li Wb, Ding Jl, Ai Sc. Effectiveness of Kinesio taping on peripheral facial paralysis: a protocol for systematic
review and meta-analysis. Medicine 2020;99:46(e23090).
Received: 5 October 2020 / Accepted: 13 October 2020
http://dx.doi.org/10.1097/MD.0000000000023090
Study Protocol Systematic Review Medicine®
OPEN
1

1. Introduction
Peripheral facial paralysis (PFP), also known as idiopathic facial
nerve paralysis, is the most common cranial nerve paralysis. Bell’s
palsy is the most common facial paralysis. PFP is a rapid
unilateral facial paralysis or paralysis of unknown etiology.
According to pathophysiological concept, it is by edema and
facial nerve primary or secondary ischemia cause nerve
compression and hypoxia. It will cause the facial muscles on
the affected side to be partially or completely unable to move
autonomously.
[1,2]
Nearly 70% of patients with PFP recover
completely, but 30% of patients leave sequela that have a
negative impact on their quality of life, both physically and
psychologically.
[3,4]
The sequela of PFP include incomplete eye
closure, crocodile tears, oral dysfunction during eating, dyspho-
nia, muscle contractures, facial joint movements, and pain.
[4–6]
Due to the inability to fully express emotions and facial aesthetics
disorders will lead to the deprivation of social functions of
patients.
[7]
Active treatment and effective intervention measures
should be taken clinically to improve clinical efficacy and reduce
sequela.
There are many treatments for PFP, such as glucocorticoids
and the use of antiviral drugs;
[8–10]
Surgical treatment such as
facial nerve decompression;
[11–13]
traditional Chinese medicine
treatments such as Chinese herbal decoction, acupuncture,
moxibustion, etc.
[6,14–16]
Physical therapy such as infrared
polarized light irradiation and transcutaneous electrical stimula-
tion.
[17,18]
In recent years, physical therapy has been widely
expanded in the treatment of PFP, Kinesio taping(KT) has also
gradually used in the rehabilitation of PFP.
[19,20]
KT was
originally developed by Japanese scientist Dr. Kenso Kase in the
1970s. The physiological effects is to lift the skin, create extra
space between the dermis and the muscles, reduce the pressure on
the pain receptors located under the skin, thereby reducing pain.
It also improves blood and lymph circulation, acting on “Gate-
control of pain”, and affect the body system through “Neuro-
facilitation”(Stimulates the mechanoreceptors of the skin,
causing positive changes to the nervous system).
[21,22]
Although KT is increasingly used in the rehabilitation of PFP,
its efficacy has not been fully proved. Up to now, there is no
systematic review (SR) on the treatment of PFP with the use of
KT. In this study, a comprehensive collection of clinical trials
related to the treatment of PFP by KT were carried out to evaluate
the effect of KT on PFP and the improvement of functions.
2. Materials and methods
The protocol for this systematic review was registered on
INPLASY (INPLASY2020100008) and is available in full on the
inplasy.com (https://doi.org/10.37766/inplasy2020.10.0008).
This SR will be reported following the Preferred Reporting
Items for Systematic Reviews and Meta-Analysis Protocol
statement guidelines.
[23]
3. Inclusion criteria for study selection
3.1. Type of studies
This review will include clinical randomized controlled trials
(RCTs) and controlled clinical trials (CCTs) of KT for PFP
patients without any language or publication status restrictions.
Case reports, case series, crossover studies, laboratory studies,
and uncontrolled trials will not be included.
3.2. Type of participants
Patients diagnosed with PFP (over 12 years old) will be included
with no restriction on gender, race, or nation.
3.3. Type of interventions
Interventions will include any type of KT for improvement of
symptoms of PFP. Studies combined with other interventions
such as conventional medication, herbal medicines, acupuncture,
moxibustion, physiotherapy will be considered for inclusion.
3.4. Type of comparators
The comparative interventions could be usual care, conventional
rehabilitations, herbal medicines, acupuncture, moxibustion, or
other active treatments.
3.5. Type of outcome measures
The primary outcome will be the total effective rate. Secondary
outcomes will include House-Brackmann scale, Portmann score,
facial nerve conduction velocity (NCV), Facial Disability Index
(FDI), Facial Disability Index include Facial Function score
(FDIp), and social Function score (FDIs).
4. Exclusion criteria for study selection
The exclusion criteria include:
1. Observational studies, case reports, cross-over trials, reviews
2. Central facial paralysis, Traumatic Facial Nerve Injury
3. Duplicated publications, requesting no results
4. Full text cannot be obtained
5. The original data is missing or incorrect, requesting no results
6. The study was divided into 3 groups or more
7. The treatment plan was not clear and the trial design was not
rigorous
5. Data collection
5.1. Search strategy
We will search the following electronic databases for
relevant trials from inception to present: China National
Knowledge Infrastructure (CNKI), Wanfang Date, SinoMed,
Technology Periodical Database (VIP), PubMed, Embase, Web
of Science and The Cochrane Library. The search strategy
was “subject terms+ free word”, there will be no language
restrictions.
5.2. Studies selection
We will use Endnote X9 to manage all the retrieved studies, and
the duplicate studies will be filtered first. Two reviewers (ZHS
and YPT) will independently screen the studies and extracted the
data respectively according to the proposed inclusion criteria and
exclusion criteria. In case of any disagreement, the 2 parties shall
discuss and negotiate, and in case of any further disagreement, the
third party expert (SCA) shall arbitrate whether to include the
dispute or not. The study selection procedure will be performed in
accordance with the Systematic Review and Meta-analysis
(PRISMA) flowchart (see Fig. 1).
Sun et al. Medicine (2020) 99:46 Medicine
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5.3. Data extraction and management
Two authors (ZHS and YPT) will read the full text and extract
the following data according to the standard data collection
form:
General information: Publication year, first author, the title of
the study;
Study methods: study design, sample size, baseline compara-
bility, randomization method, allocation concealment, blind-
ing, integrity of result data, incomplete report or selecting
report, other sources of bias;
Participants: Inclusion and exclusion criteria;
Intervention: Average age and age range of participants,
treatment duration, and frequency;
Control: Average age and age range of participants, type of
control methods, treatment duration, and frequency;
Outcomes: Outcome measures.
5.4. Risk of bias assessment
The risk of bias in included studies will be assessed independently
by 2 reviewers (YFT and DT) using the Cochrane Handbook for
Systematic Reviews of Interventions tool. A third reviewer (JLD)
will mediate in situations of any disagreement. All judgments will
be fully described, and the conclusions will be presented in the
Risk of Bias figures and will be incorporated into the
interpretation of review findings, by means of sensitivity analysis.
The risk of bias domains includes the following: random
sequence generation, allocation concealment, blinding, incom-
plete outcome data, selective reporting, and other bias. We will
fully describe all the judgments, conclusions will be presented in
the Risk of Bias figures, and incorporate interpretations of the
review results through sensitivity analysis. The risk of bias of each
domain will be judged as “unclear”,“low risk”or “high risk”.
[24]
6. Data analysis and methods
6.1. Dealing with missing data
If the primary results are lacking, incomplete, or unclear, we will
contact the original authors for the missing data via email. If the
missing data cannot be obtained from the original authors we will
analyze the available data and just do a narrative analysis.
6.2. Data analysis
We will use RevMan 5.3 software provided by the Cochrane
collaboration to process the meta-analysis. The relative risk will
be used to analyze dichotomous outcomes, while the mean
difference or standardized mean difference will be used to analyze
continuous outcomes. We will measure heterogeneity in each of
the included research questions by using the x
2
test. Fixed-effects
model will be used if there is homogeneity between the studies
(P>.1, I
2
50%). If there is obvious heterogeneity among the
studies (P.1, I
2
>50%), we will first find the 1 or more outlier
Studies identified through
datebase searching( n=# )
Additional stdudies identified
through other sources (n=#)
Studies after duplicates removed (n=#)
Studies after preliminary screening(n= #)
Exclude reviews, animal
experiments (n=#)
Include studies after browsing the full text (n=#)
Research content does not
match n=#
Observational sudies, case
reports, cross-over trials(n=#)
Other excluded studies (n=#)
Studies after re-screening by browsing abstracts (n=#)
Exclude studies (n= #)
Identification
Screening
Eligibility
Included
Figure 1. PRISMA flowchart.
Sun et al. Medicine (2020) 99:46 www.md-journal.com
3

studies that causes of heterogeneity through 3 methods: subgroup
analysis, sensitivity analysis, and meta-regression analyses. And
conduct subgroup research or delete the research that leads to
heterogeneity, and then use the fixed-effects model to merge the
effect size for meta-analysis. If the reason for the heterogeneity
cannot be found, the random-effects model can be used in the
acceptable range (I
2
<75%). If the heterogeneity is too large (I
2
≥
75%), then no merger will be carried out and only a descriptive
analysis will be done.
6.3. Subgroup analysis
If possible, we will conduct subgroup analyses based on age, sex,
treatment duration, treatment frequency, and basic treatment
(e.g., conventional medication, herbal medicines, acupuncture,
moxibustion, physiotherapy).
6.4. Sensitivity analysis
The results of one or more outlier studies will conflict with other
studies and may become a source of heterogeneity. In order to
ensure the quality of meta-analysis we will perform a sensitivity
analysis to exclude outliers.
6.5. Publication bias
Publication bias will be assessed graphically using funnel plots if a
meta-analysis includes 10 or more studies. If funnel plots are
asymmetric, we will try to interpret funnel plot asymmetry.
6.6. Ethics and dissemination
The data used in this SR will be collected based on published
studies. Based on this, no ethical approval is required. According
to the PRISMA guidelines, we will publish the results of this SR in
a peer-reviewed scientific journals.
7. Discussion
PFP is a kind of unilateral facial nerve paresis or paralysis of
unknown cause. The etiology of PFP include cold irritation, viral
infection, etc., causing inflammation, and edema in the styloid
mastoid foramen, resulting in facial nerve compression and
ischemia, causing facial nerve paralysis.
[1,25]
PFP is easy to
diagnose clinically. After treatment, most patients can recover
completely without affecting the survival rate and life expectan-
cy, and usually the prognosis is good. However, patients will
experience greater mental stress before they get better, and even
with proper treatment, up to 30% of patients develop long-term
sequela, such as permanent facial paralysis, stiffness, contrac-
ture, and facial asymmetry. Therefore, the time to complete
recovery and the effect of treatment are of great concern to
patients.
[26]
With the introduction of KT, there is an effective
method for the rehabilitation ofPFP, its mechanism of action is as
follows:
When the patient is attached to the KT, there will be obvious
muscle tension and tightness. The current situation of facial
muscle weakness and facial numbness will also be alleviated,
which is of great help to relieve patients psychological pressure
and improve patients confidence in treatment. At the same time,
KT can stimulate the skin mechanoreceptors, increase sensory
input, and proprioceptive feedback.
[27–29]
Because of its elastic effect, KT lifting the skin, increases skin
folds, reduces the pressure in the surrounding tissues of the
nerves, thereby increasing blood circulation and lymph flow,
which can promote the absorption of edema and the diffusion
and metabolism of inflammatory factors, this creates a good
internal environment for nerve recovery.
[29–32]
KT can assist muscle contraction. If the direction of KTs
tension matches the direction of muscle contraction, the recoil
force of the KT can be transmitted to the fascia. This effect
increases the excitability of the motor unit and induces muscle
spindle reflex. This strengthens the weak muscles help to realign
structures around the face and modulate muscle normal
activities.
[33,34]
However, there is still lack of valid evidence to support that KT
is effective for PFP. Therefore, the purpose of this meta-analysis is
mainly to evaluate the effectiveness and safety of KT for the
treatment of PFP. Provide reliable evidence for its wide
application. Search strategy of Embase, http://links.lww.com/
MD/F158.
Author contributions
Data curation: Yan-ping Tian.
Methodology: Ji-lin Ding, Shuang-chun Ai.
Resources: Yan-fu Tan, Dan Tao.
Supervision: Wen-bo Li.
Writing –original draft: Zai-hui Sun.
Writing –review & editing: Shuang-chun Ai.
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