Abstract
Abstract
Introduction
Several systematic reviews and meta-analyses (SRs/MAs) of clinical trials showed the efficacy of acupuncture for post-stroke motor impairment. To systematically estimate and synthesise these results, we aimed to conduct an overview of SRs/MAs to summarise the evidence and evaluate the methodological quality regarding the effectiveness and safety of acupuncture for post-stroke motor impairment.
Methods and analysis
This is a protocol for an overview of SRs/MAs. A literature search will be conducted in PubMed, Embase, Web of Science and Cochrane Central Registry of Controlled Trials from the construction of the database to March 2024. SRs/MAs evaluating the efficacy of acupuncture in post-stroke motor impairment patients will be included. Two independent investigators will screen and evaluate related SRs/MAs back-to-back. We will extract data into a predefined form designed to summarise the key characteristics of each study. The evaluation of methodological quality of the included SRs/MAs will be assessed using AMSTAR-2, the PRISMA 2020 checklist and the GRADE grading system.
Ethics and dissemination
Ethics approval is not required for this overview as we will only analyse published literature. The results will be published in a peer-reviewed journal.
PROSPERO registration number
CRD42024502006.
Keywords: stroke, motor neuron disease, complementary medicine
STRENGTHS AND LIMITATIONS OF THIS STUDY.
This overview will focus on evaluating the safety and effectiveness of acupuncture treatment for motor impairments following stroke.
This overview will include a formal assessment of the methodological quality and evidence quality of included studies.
Only articles published in English will be included.
Introduction
Post-stroke motor impairment is the most common cause of adult acquired disability that places a significant burden on healthcare globally.1 2 More than 80% of post-stroke patients experience upper or lower limb hemiplegia, seriously disturbing patients’ functional independence3 and is also associated with depression, anxiety and decreased quality of life in chronic stroke survivors.4 Exercise and training have long been used as gold-standard rehabilitation therapy to restore post-stroke motor function.5 Although intensive task-specific training has been implemented, a considerable population of stroke survivors worldwide still suffer from long-term disabilities.6 Therefore, post-stroke motor recovery requires the application of multiple therapeutic strategies.7
Rationale
As a relatively inexpensive and safe therapy, acupuncture has been widely employed to improve post-stroke neurological functions for thousands of years.8,10 Accumulating studies revealed that acupuncture could improve motor recovery and daily living activities.11,13 Numerous systematic reviews and meta-analyses (SRs/MAs) of acupuncture for post-stroke motor impairment have been published.13,16 However, there currently lacks an overview that comprehensively summarises and integrates the findings from SRs/MAs. Overviews that integrate SR/MA information offer a higher level of evidence to facilitate a deeper understanding of uncertainties and biases.17 18 Therefore, we plan to conduct the first overview to clarify the effectiveness and safety of acupuncture in promoting post-stroke motor impairment and to provide a reference for post-stroke motor rehabilitation programmes.
This overview aims to show the effect of acupuncture on post-stroke motor impairment treatment outcomes by concluding SRs/MAs. In this overview, we aim to establish whether (1) better quality SRs or clinical studies are essential and (2) acupuncture could improve post-stroke motor outcomes compared with conventional rehabilitation therapy in the short-term and long-term follow-up period.
Methods
Research registration
This protocol conforms to the Preferred Reporting Items for Systematic Reviews and Meta-Anadlyses statement and has been registered in the International Prospective Register of Systematic Reviews (no. CRD42024502006).
Search strategy
Several electronic databases will be used to conducte a literature search, including PubMed, Embase, Web of Science Core Collection and Cochrane Central Registry of Controlled Trials. A systematic search will be conducted from the database inception to January 2024. Besides, a manual review of reference lists for included studies will also be conducted to track potentially relevant studies. The search phrase included MeSH terms and keywords related to stroke, acupuncture, motor impairment and SRs/MAs. The draft searching keywords are listed in table 1. The language will be restricted to English.
Table 1. Search strategy for PubMed.
| #1 | (Stroke(MeSH Terms)) OR (Strokes(MeSH Terms)) OR (Cerebrovascular Accident(MeSH Terms)) OR (Cerebrovascular Accidents(MeSH Terms)) OR (Cerebrovascular Accident)(MeSH Terms)) OR (Cerebrovascular Apoplexy(MeSH Terms)) OR (Brain Vascular Accident(MeSH Terms)) OR (Brain Vascular Accidents(MeSH Terms)) OR (Cerebrovascular Stroke(MeSH Terms)) OR (Cerebrovascular Strokes(MeSH Terms)) OR (Stroke, Cerebrovascular(MeSH Terms)) OR (Apoplexy(MeSH Terms)) OR (Cerebral Stroke(MeSH Terms)) OR (Cerebral Strokes(MeSH Terms)) OR (Acute Stroke(MeSH Terms)) OR (Acute Strokes(MeSH Terms)) OR (Acute Cerebrovascular Accident(MeSH Terms)) OR (Acute Cerebrovascular Accidents(MeSH Terms)) |
| #2 | (Stroke(Title/Abstract)) OR (Strokes(Title/Abstract))) OR (Cerebrovascular Accident(Title/Abstract))) OR (Cerebrovascular Apoplexy(Title/Abstract))) OR (Brain Vascular Accident(Title/Abstract))) OR (Apoplexy(Title/Abstract))) OR (Cerebral Stroke(Title/Abstract))) OR (Acute Stroke(Title/Abstract)) |
| #3 | #1 OR #2 |
| #4 | (Dyskinesias(MeSH Terms)) OR (Dyskinesia(MeSH Terms))) OR (Abnormal Movement(MeSH Terms)) OR (Abnormal Movements(MeSH Terms)) OR (Movement, Abnormal(MeSH Terms)) OR (Movements, Abnormal(MeSH Terms)) OR (Hemiballismus(MeSH Terms)) |
| #5 | (Paralysis(MeSH Terms)) OR (Paralyses(MeSH Terms)) OR (Palsy(MeSH Terms)) OR (Palsies(MeSH Terms)) OR (Plegia(MeSH Terms)) OR (Plegias(MeSH Terms)) |
| #6 | (Dystonia(MeSH Terms)) OR (Dystonia Disorders(MeSH Terms)) OR (Muscle Dystonia(MeSH Terms)) |
| #7 | (Hemiplegia(MeSH Terms)) OR (Hemiplegias(MeSH Terms)) OR (Monoplegia(MeSH Terms)) OR (Monoplegias(MeSH Terms)) OR (Hemiplegia, Crossed(MeSH Terms)) OR (Crossed Hemiplegia(MeSH Terms)) OR (Crossed Hemiplegias(MeSH Terms)) OR (Hemiplegias, Crossed(MeSH Terms)) OR (Hemiplegia, Flaccid(MeSH Terms)) OR (Flaccid Hemiplegia(MeSH Terms)) OR (Flaccid Hemiplegias(MeSH Terms)) OR (Hemiplegias, Flaccid(MeSH Terms)) |
| #8 | (Motor function(Title/Abstract)) OR (motor impairment(Title/Abstract)) OR (Motor Disorder(Title/Abstract)) OR (Movement Disorder(Title/Abstract)) OR (Movement impairment(Title/Abstract)) OR (Movement function(Title/Abstract)) OR (Motor(Title/Abstract)) OR (movement(Title/Abstract)) |
| #9 | #4 OR #5 OR #6 OR #7 OR #8 |
| #10 | (Acupuncture Treatment(MeSH Terms)) OR (Acupuncture Treatments(MeSH Terms)) OR (Acupuncture Therapy(MeSH Terms)) OR (Acupuncture Therapies(MeSH Terms)) OR (Pharmacoacupuncture Treatment(MeSH Terms)) OR (Pharmacoacupuncture Therapy(MeSH Terms)) OR (Acupotomy(MeSH Terms)) OR (Acupotomies(MeSH Terms)) OR (Electroacupuncture(MeSH Terms)) OR (Acupuncture, Ear(MeSH Terms)) |
| #11 | (Acupuncture(Title/Abstract)) OR (Electroacupuncture(Title/Abstract))) OR (Acupotomy(Title/Abstract))) OR (Pharmacoacupuncture Treatment(Title/Abstract))) OR (Acupuncture Therapy(Title/Abstract))) OR (Acupuncture Treatment(Title/Abstract)) |
| #12 | #10 OR #11 |
| #13 | (Systematic Review(Publication Type)) OR (Meta-Analysis(Publication Type)) |
| #14 | (Systematic Reviews as Topic(Mesh)) OR (Umbrella Reviews as Topic(MeSH Terms)) OR (Reviews Systematic as Topic(MeSH Terms)) |
| #15 | (Meta-Analysis as Topic(Mesh)) OR (Data Pooling(MeSH Terms)) OR (Clinical Trial Overview(MeSH Terms)) |
| #16 | (systematic review(Title/Abstract)) OR (system review(Title/Abstract)) OR (data pooling(Title/Abstract)) OR (clinical trial overview(Title/Abstract)) |
| #17 | #13 OR #14 OR #15 OR #16 |
Eligibility criteria
The literature comparing outcomes between acupuncture and non-acupuncture for post-stroke motor impairment will be included. Study patients who were diagnosed with post-stroke motor impairment will undergo acupuncture or conventional treatment (don't include acupuncture therapy). Post-stroke motor impairment is defined as a certain degree of dysfunction in limb movement compared with healthy individuals after ischaemic stroke, encompassing motor deficits caused by flaccid hemiplegias or dystonic disorders. The outcomes will include functional assessment and adverse events. The exclusion criteria will be the following: (1) non-human studies, (2) non-comparative studies, (3) studies that do not include post-stroke motor impairment, (4) studies without available data can be extracted and (5) non-original studies (letters reviews and editorials).
Study records
Selection process
EndNote V.X9 software will be used to store and manage the retrieved studies, and duplicate publications will be excluded. Two independent reviewers will conduct a preliminary scan of the title and abstract of the retrieved articles for potentially relevant studies. Disputes arising during the review process will be resolved by a neutral third-party reviewer. The flow diagram of the study selection process is presented in figure 1.
Figure 1. Schematic diagram of the screening process. Notes: MAs, meta-analyses; SRs, systematic reviews; PSMI, post-stroke motor impairment.
Data extraction
The data extraction will be performed by two independent reviewers according to a predefined data collection form. The data extraction process will encompass the following considerations: (1) details of the SR/MA publication (authors’ name, publication dates, number of included studies and total participants), (2) participants’ characteristics (age, sex, type of stroke, and days from stroke onset), (3) details of interventions in the treatment and control groups (treatment period, type of intervention), (4) description of outcome measures (primary outcome measurement, secondary outcome measurement), (5) acupuncture-related adverse events, (6) results of risk-of-bias assessment, and (7) summary effect sizes (study-specific standardised mean difference (SMD), 95% CIs).
Two reviewers will cross check the extraction results of the extracted studies. Any discrepancies will be resolved by a third reviewer.
Outcomes measures
The primary outcomes will be defined as the average overall change in motor-related functional assessment. The included SRs/MAs will be required to report at least one of the following outcomes: (1) motor function-related assessment scales, including the Fugl–Meyer assessment (FMA),19 Modified Ashworth scale (MAS)20 or Berg balance scale;21 (2) measurement of the range of motion, including goniometer; and (3) muscle strength, including manual muscle testing. The secondary outcomes will consider activities of daily life (ADLs), pain intensity assessment, emotional state function and adverse events. The impairment of ADLs is one of the impacts of stroke, and the assessment of ADL can provide a comprehensive evaluation of the consequences of post-stroke motor impairment. Additionally, post-stroke limb pain and emotional disorders are common comorbidities in stroke patients, and attention to these outcomes can facilitate a multifaceted evaluation of the comprehensive effects of acupuncture.
Quality assessment
Two independent reviewers will conduct back-to-back quality evaluation of the included studies. Any disagreement during the assessment procedure will be resolved through discussion or adjudication with a third reviewer.
The methodological quality of each included SR/MA will be assessed using the AMSTAR-2 tool.22 The AMSTAR-2 tool has been specifically developed for SRs encompassing randomised or non-randomised studies. AMSTAR-2 comprises 16 items, with each item offering four potential responses: ‘yes’ (definite completion), ‘no’ (definite non-completion), ‘can't report’ (uncertainty regarding completion) and ‘not applicable’. The quality of each item will subsequently be grouped into four distinct levels: critically low, low, medium and high.
Additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system will be used to assess the evidentiary quality of each SRs/MAs,23 downgrading from five aspects: research limitations, inconsistency, indirectness, imprecision and suspected publication bias. According to the GRADE working group’s recommendations, we will grade the quality of evidence into four levels: high, medium, low and very low.
Data synthesis and analysis
Statistical analysis will be performed with Review Manager V.5.4 software. The qualitative analysis of the summary effect size for each SR/MA will be conducted using the SMD and its corresponding 95% CI. If there were no SMDs expressed in the original studies, the results will be converted to SMDs using Review Manager V.5.4 software. If data are insufficient and cannot be converted, we will extract the data from the original randomised controlled trial and process it according to the instructions by the Cochrane Collaboration. Heterogeneity will be reported using the I2 statistic, where values ranging from 0% to 25% suggest no heterogeneity, 25% to 49% suggest low heterogeneity, 50% to 74% suggest moderate heterogeneity, and values above 75% suggest high heterogeneity.
The I2 statistic will be used for reporting heterogeneity: with 0% to 25% indicating no heterogeneity, 25% to 49% indicating low heterogeneity, 50% to 74% indicating moderate heterogeneity, and above 75% indicating high heterogeneity. Publication bias will be assessed through the funnel plots.
Subgroup analyses
We will deliver the following subgroups analysis: (1) for the type of acupuncture therapies received by participants (eg, dry needling, electroacupuncture or other acupuncture therapy), (2) for the recovery of the upper and lower limb, and (3) for the duration of the intervention period.
Ethics and dissemination
This overview is a secondary study based on published clinical research. We only analyse published studies and do not collect primary data or individual patient information. Therefore, ethics approval is not required. The results of this study will be published in peer-reviewed journals.
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-086427 ).
Patient consent for publication: Not applicable.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Contributor Information
Pei Yu, Email: shenjiedeyue@163.com.
Yaning Liu, Email: eric_liu0225@163.com.
Haorun Wang, Email: forester@163.com.
Tangming Peng, Email: pxtxmx@126.com.
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