Tuina for spasticity of poststroke: protocol of a systematic review and meta-analysis

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  1. http://orcid.org/0000-0003-0594-1654Qiongshuai Zhang1,
  2. Guangcheng Ji2,
  3. Fang Cao3,
  4. Yihan Sunfour,
  5. Guanyu Hu1,
  6. Shaoqian Sunday5,
  7. Yanze Liu1,
  8. Jiazhen Caoi,
  9. Yufeng Wang6,
  10. Xiaohong Xu7,
  11. Bailin Vocalone
  1. 1 Acupuncture and Tuina Department, Changchun University of Chinese Medicine, Changchun, Mainland china
  2. 2 Rehabilitation Medicine Department, Changchun University of Chinese Medicine, Changchun, Communist china
  3. three Acupuncture Department, Henan Academy of Traditional Chinese Medicine, Zhengzhou, China
  4. iv TCM Section, Changchun Academy of Chinese Medicine, Changchun, People's republic of china
  5. v Rehabilitation Medicine Department, Jilin University Third Affiliated Hospital, Changchun, Communist china
  6. 6 Tuina Department, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Mainland china
  7. 7 Graduate Schoolhouse, Changchun University of Chinese Medicine, Changchun, Cathay
  1. Correspondence to Professor Bailin Vocal; jlsongbl{at}126.com

Abstract

Introduction Spasticity is a mutual complication of poststroke, tuina is a widely used rehabilitation treatment, although in that location is a lack of supportive testify on efficacy and safe for patients with poststroke spasticity. The aim of this systematic review is to appraise and synthesis evidence of efficacy and safety of tuina for spasticity of poststroke.

Methods and analysis A comprehensive electronic search of EMBASE, MEDLINE, Cochrane Library, Spider web of Scientific discipline, Wiley, Springer, PEDro, Chinese Scientific discipline Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific and Journal Database (VIP), Wanfang Database (Wanfang), Japanese medical database (CiNii), Korean Robotics Institute Summer Scholars and Thailand Thai-Journal Citation Index Centre will be conducted to search literatures of randomised controlled trials of tuina for spasticity of poststroke survivors range from the establishment to ane January 2020.

There is no fourth dimension of publication limitations. The primary outcome volition be measured with the Modified Ashworth Scale, and the 2d outcome will include Fugl-Meyer Cess Scale, surface electromyogram RMS value, the Modified Barthel Index, Stroke Specific Quality of Life Calibration, quality of life 36-Item Brusque-Form Health Survey and Visual Analogue Scale. Cochrane Handbook for Systematic Reviews of Interventions will be used to assess the take chances of bias, and GRADE volition be used to access the conviction in cumulative testify. The protocol will be conducted according to approach and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015.

Ethics and broadcasting Ethical approval will not exist required, for no primary data of private patients were collected. We will publish the findings in a peer-reviewed periodical.

PROSPERO registration number CRD42020163384.

  • stroke medicine
  • limb reconstruction
  • rehabilitation medicine

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This is an open access article distributed in accordance with the Artistic Commons Attribution Non Commercial (CC By-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this piece of work non-commercially, and license their derivative works on dissimilar terms, provided the original work is properly cited, appropriate credit is given, whatever changes made indicated, and the apply is not-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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  • stroke medicine
  • limb reconstruction
  • rehabilitation medicine

Strengths and limitations of this study

  • This is the first comprehensive systematic review focused on efficacy and safety of tuina for spasticity of poststroke.

  • Only randomised controlled trials (RCTs) (not included quasi-RCTs) volition be included in this report.

  • We searched databases of English, Chinese, Japanese, Korean and Thailand, while other languages may exist ignored.

Stroke has been the starting time take a chance factor of death in People's republic of china.1 It is also one of the diseases with high bloodshed and inability rate in the globe.2 Limb spasticity is a common complication of poststroke patients.iii 4 Recent report shows that about 17%–43% of stroke patients had limb spasticity,5–7 and the medical price of patients with poststroke limb spasticity is well-nigh four times as much as poststroke patients without spasticity.8 9 Limb spasticity not merely severely restricts the power of patients, reduces the quality of life, but also causes psychological impact on patients' rehabilitation, and brings a great burden to families and gild.10–14

Physical therapy, oral or injection drug therapy and operation therapy are commonly used in Western medicine to treat poststroke spasticity at present. Oral drugs such equally baclofen, eperisone, hydrochloride and diazepine have large side effects which hinder the recovery of motor function with long time taking.15 Botulinum toxin treatment is hard to achieve long-term results, and information technology is oftentimes injected for moderate or severe cases of poststroke spasticity.16 17 Physical therapy often requires active exercise coordination of patients; however, patients with severe conditions are often unable to cooperate. Surgical treatment is traumatic and a big number of patients frequently detect it difficult to accept. Now, much more of the patients with spasticity afterwards stroke choose external handling. In China, many external treatment methods of traditional Chinese medicine (TCM) are practical to the treat this disease.

Tuina is an ancient form of external handling method, which was based on the meridian and acupoint theory of TCM, and uses specific functioning skill acting on the surface or acupoints of the patient'due south body to treat diseases.18 nineteen Tuina has been widely used in China for hundreds of years and increasingly practiced in Western countries in recent years. Systematic evaluation20 shows that acupuncture is efficacy and prophylactic in the handling of limb spasticity afterwards stroke. Acupuncture and tuina belong to the external treatment of TCM, and both are based on the same theory of meridians and acupoints. However, it is nevertheless unclear whether the effectiveness of acupuncture is as well applicable to tuina in the treatment of poststroke spasticity. We want to know the consequence of tuina, which has the characteristics of intervention and low toll, for poststroke spasticity. At present, there is no systematic review of tuina in the treatment of poststroke limb spasticity, and then this study volition evaluate the efficacy and safe of tuina in the treatment of poststroke limb spasticity, and provide testify for clinical determination-making of massage.

Methods

The systematic review volition be performed following the guideline of Preferred Reporting Items for Systematic Review and Meta-Assay Protocols (PRISMA-P) 2015.21

Inclusion criteria

Types of studies

Nosotros will include randomised controlled trials (RCTs) (not included quasi-RCTs) of tuina for poststroke spasticity in the treatment groups. If multiarm RCTs comes, nosotros will select the group which used tuina and some other without tuina for analysis. We will select the first stage of cantankerous over RCTs, in which tuina was first used in ane group. RCTs' linguistic communication of English, Chinese, Japanese, Korean and Thai will be included.

Types of participants

Patients suffering postacute phase of mail-stroke spasticity (>18 years one-time) will be included. Stroke (cerebral infarction or cerebral haemorrhage) is diagnosed according to WHO criteria,22 participants have the symptoms of limb musculus tension increase, and the Modified Ashworth Scale (MAS) score is grade 1–2. Participants of any sex and ethnicity will exist enrolled.

Types of interventions

The handling group using tuina while the command group receives handling of oral medication, acupuncture, Chinese herbal medication, concrete therapy, surgery, botox injections and so on or even with no treatment will exist included.

Types of consequence measures

Primary outcome

Muscle tone volition be evaluated by the MAS. MAS is a clinical instrument which is ordinarily used for measuring spasticity, and studies have proofed its reliability.23–25

Secondary result

Motor part was assessed with Fugl-Meyer Assessment Scale (FMA) or Simplified FMA Calibration.

Muscle force will be defined by surface electromyogram root mean square value (RMS).

Activities of daily living will be assessed by the Modified Barthel Alphabetize.

Quality of life will be measured by Stroke Specific Quality of Life Scale or quality of life 36-Item Short-Form Health Survey (SF-36).

Limb pain will be assessed by Visual Analogue Scale.

Safety outcome

Skin abrasions.

Exclusion criteria

  • Repeatedly published studies.

  • Experiences, letters, systematic reviews and brute experiments.

  • Tuina was not only in the experimental grouping simply too in the control group.

  • Articles without total text or with data which are missed or cannot be used.

Search strategy

Electronic searches

The published electronic literature will exist searched in EMBASE, MEDLINE (by PubMed), Cochrane Library, Spider web of Science, Wiley, Springer, PEDro, Chinese Science Citation Database, Mainland china National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific and Journal Database (VIP), Wanfang Database, Japanese medical database (CiNii), Korean Robotics Institute Summertime Scholars and Thailand Thai-Journal Citation Index Centre. We volition also cheek reference lists, and the literature will exist searched range from the establishment to 1 January 2020.

The search strategy is developed according to published reviews.26 27 The item search strategy of MEDLINE (past PubMed) is listed in table 1, while the search strategy will be modified according to other unlike databases.

View this table:

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Table 1

MEDLINE (by PubMed) search strategy

Data collection and analysis

Pick of literature

Two authors (YL, JC) volition place studies according to the inclusion criteria independently. Start, they volition eliminate indistinguishable researches by using EndNote software (V.x9.0). 2d, screening the championship and abstract, if necessary, reading the total commodity to confirm if it should be included. They as well apply EndNote software to manage the included studies. The screening operation is performed as shown in figure 1. If there is disagreement during the screening process, discuss with the third experts (GJ) to make a decision.

Data extraction and management

Two authors (SS and YW) volition extract data from the included studies independently. In multiarm RCTs, nosotros will extract information from RCTs of two arms, while we volition select one group which contains the treatment of tuina every bit the treatment group, we will too choose another grouping the treatment of which without tuina equally the command group. The general information consists of title, publication yr, authors, country, language and periodical source; information of participants: gender, age, stroke blazon (cerebral infarction or cerebral haemorrhage), elapsing of onset and sample size; data of intervention characteristics: blazon, session, elapsing and follow-upwards time and outcome data well-nigh primary upshot, second outcome, observation time points and adverse effects.

Cess of risk of bias in included studies

Two contained authors (QZ and FC) will evaluate the risk of bias past using the Cochrane Collaboration bias risk assessment tool to assess the run a risk bias of the literature included in the systematic review. The 2 authors volition appraise the risk of bias of sequence generation, allocation concealment, blinding of participants personnel and outcome assessment, incomplete effect data, selective result reporting and other bias. The evaluation grades are low, loftier and unclear risk of bias.

Measures of handling outcome

2 independent authors (YS and QZ) volition use the mean difference (Physician) or standard Dr. with 95% CI for continuous data of final measurements, the other binary information volition be changed into relative risk (RR) class.

Dealing with missing data

When the included commodity lacks some important information, we will effort to contact the correspondence author through email, telephone or other contacts. If nosotros can't get the information through the ways above, we volition turn to the following strategies to evaluate the potential influence of missing information:28

  • Worst-case scenario analysis: all participants with missing information counted as failures.

  • Extreme worst-instance/all-time-instance scenario analysis: participants with missing consequence information in the exercise arm counted every bit failures and in the control arm every bit success and vice versa.

Assessment of heterogeneity

We will utilise Q-test and I2 statistic to appraise the heterogeneity of the included studies, as the criteria: I2 <50% indicates low heterogeneity, while I2>fifty% indicates high heterogeneity,

Assessment of reporting bias

We will construct funnel plots to assess asymmetry, just if at least 10 RCTs are included.

Information synthesis

The meta-analysis of intervention and outcome measures methods will be conducted past RevMan V.5.3.5 software (the Cochrane Collaboration, Oxford, England). If the statistical heterogeneity is low (P>0.i, or Itwo<50%), we will utilize the fixed-result model to combine the data, while if the statistical heterogeneity is loftier (P<0.1, or Iii>fifty%), we will use the random-event model. Nevertheless, if the heterogeneity level much significant, a descriptive analysis will be performed.

Subgroup analysis and investigation of heterogeneity

Nosotros will perform subgroup analysis to assess heterogeneity of the report co-ordinate to the following potential factors from the available sufficient data:

  • Age.

  • Sex.

  • Different types of stroke (Cognitive haemorrhage or cerebral infarction).

  • Different types of tuina.

  • Different time/course of handling.

  • Unlike parts of affected limbs (upper limb or lower limb).

  • Dissimilar types of command group (acupuncture, placebo, oral/injection drug or no treatment).

Nosotros may make meta-regressions co-ordinate to age and the different fourth dimension/course of handling if heterogeneity is obvious.

Sensitivity assay

We will perform the sensitivity assay to evaluate the robustness and reliability of the pooled results. If the results are not stable, we may turn to removing studies of high hazard of bias, or cheek up processing method of missing information (worst-example scenario analysis: all participants with missing data counted as failures; extreme worst-case/best-case scenario analysis: participants with missing event information).

Grading of testify quality

We volition utilize the Grading of Recommendations Assessment, Development and Evaluation29 to access the confidence in cumulative evidence. Take a chance of bias, heterogeneity, indirectness, imprecision and publication bias will be assessed, and the results will be divided into four levels: high, moderate, depression and very low.

Amendments

We volition show all the amendments with detailed description and rationale in the amendments of this study.

Ethics and dissemination

There is no demand of upstanding approval in this report, because at that place is nothing of the data which has a relationship with an individual patient. We will consummate this systematic review according to the PRISMA guidelines. The review will provide an assessment of effect and safety of tuina for spasticity of poststroke. We volition publish the findings in a peer-reviewed, open assess journal and the finished systematic review and meta-assay will exist disseminated online, which would be obtained freely for anyone. The results may contribute to improving the therapeutic strategy of patients with poststroke spasticity.

Patient and public involvement

No patient or public volition be involved in our study direct. We just use data that existed in studies published.

Discussion

This systematic review will focus on the efficacy and rubber of tuina for spasticity of poststroke. Tuina is a traditional Chinese physical therapy, which is effective for 516 diseases in China,30 of which spasticity is included. Clinical reports show tuina is well in treatment of spasticity of poststroke; nevertheless, high-quality written report withal did not announced. Nosotros conducted this review with the aim to provide meliorate evidence and guide for clinical determination-making. We program to publish this review inside one year since the protocol published, then nosotros will update it every three years.

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© Author(s) (or their employer(s)) 2020. Re-use permitted nether CC Past-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC Past-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this piece of work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. Run into: http://creativecommons.org/licenses/by-nc/4.0/.