This scoping review protocol was finished in accordance with the relevant sections of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guideline [45]. The final version of this review will be completed under the principle of the Guidance for Conducting Systematic Scoping Reviews [46].
When a science is emerging, a scoping review is of great importance. It allows for a broad view of the nature and range of evidence of a given topic [47]. Besides, it offers a framework which would allow for greater breadth to include all pertinent acupuncture researches employing tbfMRI, irrespective of quality. What’s more, this approach can be applied to examine and identify the gaps in the evidence.
Research questions:
The purpose of this scoping review is to identify, examine and summarize the status of the design of acupuncture mechanism study employing task-based fMRI. The research questions guiding this review are:
What are the research scope and characteristics of the published literature on acupuncture employing task-based fMRI?
How can we conduct an acupuncture task-based fMRI study?
Inclusion criteria:
Participants:
This review will include the clinical studies conducted on human beings. Subjects can be healthy volunteers or patients in a pathological state, and their disease, gender, age, handedness, allocation of the groups, drop out, and other basic information will be extracted as results. Besides, the pathological state of subjects in one study should be accordant with those in the other.
Concept:
The studies discussed in this review should be those that take acupuncture as the only or the main intervention, employ tbfMRI as an outcome measurement and are completed with detailed descriptions.
Traditional acupuncture intervention types (manual acupuncture, electro-acupuncture, scalp needle, auricular acupuncture) will be considered while the moxibustion and unconventional acupuncture interventions (laser acupuncture, dry acupuncture, catgut embedding acupuncture, intradermal needle, or floating needle) will be excluded.
Task-based fMRI will be the focus of the study, in which acupuncture performance is designed in the task to explore its instant or sustained effects. Besides, the studies that only apply rest-state fMRI will be excluded. Most literature does not clearly explain the paradigms of design, so a full-text review of each fMRI-employed study is needed to identify whether it will be included. For the case-controlled trials conducted in a pathological state, an outcome measurement for therapeutic evaluation is necessary to demonstrate the effect of acupuncture, and it should be connected with fMRI results.
Context:
This review will explore the eligible clinical studies included by 6 databases of PubMed, Embase, Cochrane, Chinese National Knowledge Infrastructure (CNKI), WanFang database and VIP database. The year range of publication shall be from the inception of the databases to June 2020. The language shall be Chinese or English.
Study types:
The review will include the experimental or quasi-experimental study of randomized controlled trials, non-randomized controlled trials, cross-over design trials, and case series studies. However, the small sample case reports which mainly focus on clinical effects will be excluded.
Search strategy:
The initial search was finished by having a quick browse of topics of interest on PubMed and it was confirmed that there were no similar studies. Besides, the keywords needed in the search were determined.
The systematized search will be conducted in the 6 databases of 3 in English language and 3 in Chinese language, PubMed, Embase, Cochrane, CNKI, WanFang database and VIP database. Articles in other languages will be excluded. The year range will be set from the inception to June 30th, 2020. The whole searching strategy of PubMed is demonstrated in table 1.
Table 1
Search strategy used in PubMed database
NO.
|
Search Items
|
1
|
fMRI
|
2
|
functional MRI
|
3
|
functional Magnetic Resonance Imaging
|
4
|
OR/1-3
|
5
|
Acupuncture
|
6
|
acupuncture therapy
|
7
|
electroacupuncture
|
8
|
Acupoint
|
9
|
OR/5-8
|
10
|
4 AND 9
|
The reference list of all the identified articles will be searched again for additional studies. Reviews, diploma dissertations, conference articles, animal studies, and protocol for studies will not be involved.
Study selection:
Following the search, all identified studies will be uploaded to Endnote X9.2 and duplicates will be removed. The non-English language articles from PubMed will also be removed. Titles and abstracts will be screened by two independent reviewers (YY and SRY) guided by the inclusion criteria. If a study cannot be identified whether it is eligible or not from titles and abstracts, the full text will be browsed. Then, the 2 reviewers will conduct a full-text review of the selected studies to further exclude the ineligible studies. Next, those literatures will be cross checked and problems will be solved by the 2 reviewers. If there are any disagreements, the decision will be made by a third reviewer (CHZ). The process and results of studies selection will be presented in figure 1.
Data extraction:
Data will be extracted from eligible articles using Excel 2019. The data extraction table will be developed based on the data items detailed below. Any disagreements between the 2 reviewers will be solved through discussion or by referring to a third reviewer. Missing data will be obtained by contacting the author through mail. Modifications will be detailed in the final scoping review.
Data items:
The following data items will be collected during the data extracting process:
Publication characteristics (title, author, year of publication, country of study, the language of the report).
Study design (objective of the study, controlled method or not, numbers of group, sample size, drop out)
Characteristics of participants (state or disease of participants, age, gender, handedness)
The paradigm of acupuncture task (block-design, signal block, modified block, event-related, NRER, repeated measure NRER, mix design)
Details of acupuncture intervention (acupoints, needle stimulation, response sought, needle retention time or not, numbers of experiment and their interval, texture of needle, other components of the intervention, controlled intervention, practitioner)
Details of fMRI acquisition (brand of fMRI scanner, magnetic field intensity, TR and TE of the scan, the state of subjects under scanning, numbers of process, duration of each process)
Details of data preprocessing (Standard Template, statistical method, other additional measurements)
Result presentation:
The extracted data will be presented in the form of graphs or tables in a manner that aligns to the objective and scope of this scoping review. A qualitative thematic analysis will be undertaken to provide an overview of the literature. Each table or chart will be accompanied by a narrative summary describing how the results relate to the review objectives and questions. The findings will be discussed based on practice and research, and a conclusion which is helpful to the future studies in this field will be drawn.