The aim and objective
This systematic review protocol aims to determine the efficacy and securityof Motion style acupuncture treatment for acute lumbar sprain.
Study design
The systematic review has been registered on PROSPERO with a registration number of CRD42020192876. This study will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) checklist (see Additional file 1 for completed checklist) [31] and will be conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions.[32]
Information sources and search trategy
The related databases including PubMed, SoniMed, Cochrane Library, EMBAS, Springer, China National Knowledge Infrastructure(CNKI), Wanfang data, and Chinese Biomedical Literature Database(CBM) will be searched. All RCTs published in electronic databases from inception to February 1st, 2021 with language restricted in Chinese and English will be included. Medical Subject Headings (MeSH) and variants for“acute lumbar sprain”, “acupuncture”, and “motion therapy”will be used and combined in the searches. The primary selection process is shown in the PubMed search strategy (see table 1).
Eligibility criteria
Types of studies
Randomized controlled trials (RCTs) of motion style acupuncture treatment (MAST) for acute lumbar sprain. A randomized study was conducted if the trial stated the“randomization”phrase, and blinding was not restricted. The case reports, animal mechanism studies, self-pre and post-control, expert experience, duplicated publications, or non-RCTs will be excluded.
Types of participants
Inclusion criteria
According to the guidelines for diagnosis and treatment of low back pain (2019)[33], participants(aged ≥ 18 years) of acute lumbar sprain with 1. history of acute lumbar sprain; 2. often occurs in the low back segment; 3. acute low back pain and limited activity; 4.obvious pain points, muscle spasm, and stiffness will be included.
Exclusion criteria
Participants with nerve sexual pain, vertebral infection, neoplastic low back pain, low back pain from internal viscera, spinal fracture dislocation, acute medical conditions, and pregnant women will be excluded on account of actual clinical conditions.
Types of interventions
Motion style acupuncture treatment (MSAT) in this study included all types of acupuncture combined with motion threads, such as electroacupuncture, dry-needle, auriculotherapy, superfcial needling, acupressure, abdominal acupuncture, bleeding therapy, warm acupuncture, blade needle, eye acupuncture, needle knife, and so on. Studies comparing the effects of different acupuncture treatments will be excluded.
Types of control groups
The intervention groups included pure acupuncture therapy, exercise therapy, pharmacotherapy, sham-acupuncture, placebo, or no additional intervention to usual care. Studies that compared different acupoints will be excluded.
Types of outcome measures
Studies will include one or more of the following outcomes.
The primary outcomes:
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Effective rate.
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The change in pain intensity was identified using a visual analogue scale (VAS) or numeric rating scale (NRS).
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Functional outcome measures were identified using the range of motion (ROM).
The Secondary outcomes:
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Quality of life measured by validated scales includes SF-36 or other validated outcome measures.
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Dysfunction questionnaire score using oswestry disability index (ODI).
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Treatment frequency and courses.
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Side effects, including pneumothorax, bleeding, serious discomfort, subcutaneous nodules, and infection, will be recorded.
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The number of participants dropped out, and the number of participants reporting adverse events was also recorded.
Data collection and analysis
Two independent reviewers( JW and DZ) independently will scan the titles and abstracts according to the inclusion criteria and screen articles by their full-text version. They will extract the data into a self-designed data extraction form if it satisfies the inclusion and exclusion criteria; finally, they will cross-check the selection results. Any disagreements will be arbitrated by a third reviewer (SJ). The selection procedure is shown in a PRISMA flow diagram (see Additional file 2).
Data extraction and management
The data extraction form will include basic information (article title, first author, publication year, country, mean age of the population, number of males and females), study design (RCT design, blind method, randomization, sample size), interventions (including the methods, frequency and duration of interventions), outcome measures, adverse effects, duration of follow-up, conclusions, and source of financial support according to the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist.[34] The completed data extraction forms were cross-checked by the two reviewers. Any diversity will be resolved by a third reviewer (SJ).
Assessment of risk of bias and quality
Two reviewers (JW and JM) will assess the risk of bias of included trials by the Cochrane Collaboration’s risk of bias assessment method. We assessed the risk of bias (low, high and unclear risk) in six areas including performance bias (blinding of participants and personnel), selection bias (random sequence generation, allocation concealment), detection bias (blinding of outcome assessment), attrition bias (incomplete outcome data), reporting bias (selective reporting), and other biases. For duplicate publications, we only select the original. The final decisions will be made by the third reviewer (JS) if inconsistent results appear.
Measures of treatment effect
The mean differences (MDs) with 95% confidence intervals (95% CIs) were used for continuous data. Other forms of data will be changed to MD values. The risk ratio with 95% CIs will be used to analyze dichotomous outcomes. Ordinal outcomes (e.g., ‘almost cured, remarkably effective, effective, or ‘not effective’) in two or more categories will be transformed into dichotomous outcomes such as responders and non-responders. A random-effects mode will be used if significant heterogeneity is detected.
Management of missing data
For incomplete data or missing data, we will contact the corresponding author to request additional information. If we not get the incomplete data or missing data, it will be excluded from analysis.
Assessment of heterogeneity
Review Manager software (V.5.3) will be used to assess the curative effect and publication bias. The relative strength of the curative effect will use the Forest plot to illustrate. Meanwhile, if trials are more than 10, the funnel plot will be used to assess the publication bias visually. In addition, subgroup analyses or meta-regression will be used to explore the source of heterogeneity.
Data analysis
We will use the Review Manager (V.5.3) for data analysis if there are two or more studies of sufficient homogeneity across the outcome measures to ensure pooling. Heterogeneity was analyzed using the I2 statistic. The RR and MD will be calculated by a fixed-effects model, if I2 < 50%. A random-effects model will be used to synthesize the data, if I2 ≥ 50%. We will use subgroup analysis or sensitivity analysis to explore the causes of heterogeneity such as clinical or methodological reasons. When the quantitative evaluation is not available, we will provide a qualitative description of the results of the individual study.
Narrative analysis
Narrative synthesis will be used if meta-analysis is not appropriate (e.g., incidence of adverse events of acupuncture).
Subgroup analysis
We will conduct a subgroup analysis according the control intervention and different results.
Sensitivity analysis
Sensitivity analysis will be conducted according to several nodes such as methodological weaknesses, sample size, missing data, and statistical models.
Grading the quality of evidence
The quality of evidence for outcomes will be independently assessed by two reviewers using the Grading of Recommendations Assessment, Development and Evaluation guidelines (GRADE).[35] The strength of the body of evidence is divided into four levels: high, medium, low, and very low. [36]