Background: Pregnancy-related low back pain (PLBP) affects the daily living activities of pregnant women, even leading to fetal agitation and threatened abortion. Kinesio taping (KT) can improve the circulation of blood and provide elastic supports, which is a reliable method to treat low back pain. At present, although many studies have been published on the effects of KT on PLBP, the results are inconsistent, and some studies even report that KT does not affect PLBP. there is still a lack of high-level clinical evidence for the treatment of PLBP with KT. Therefore, this study proposes a protocol for a systematic review and meta-analysis of published Randomized Controlled Trials (RCTs) to evaluate the efficacy and safety of KT for PLBP.
Methods: This protocol is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. We will search the following database sources of the RCTs: PubMed, the Cochrane Library, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science, and the Wanfang Database. From the establishment of the database to April 2021. The retrieval word adopts the combination of theme words and free words. Take "Kinesiotape, Tape Athletic, Orthotic Tape, Athletic Tape, Pregnancy, Pregnancies, Gestation, low back pain" as a term for retrieval. Two independent investigators will conduct an electronic literature search, study selection, data extraction, and quality assessment to summarize and evaluate the efficacy of KT in the treatment of PLBP. Retrospective trials are not included, and the risk of bias will be assessed using the Cochrane bias risk tool. All data analysis will be conducted using Revman5.3 software.
Results: Quality outcomes in systematic review studies depend on inclusion and search criteria to obtain high-quality data, as well as how the data are processed and interpreted. Among the results, this study will objectively and comprehensively evaluate the efficacy and safety of the randomized controlled trial of KT in the treatment of PLBP, and make a detailed analysis of the effect of KT in the treatment of PLBP. The results will be analyzed by the Visual Analogue Scale of Pain and the Roland Morris Dysfunction Questionnaire. If applicable, a subgroup analysis will also be performed, which will be grouped according to the duration of pregnancy, grade of pain, etc. Finally, the results are submitted to a peer-reviewed journal for publication.
Conclusion: Based on the results, this study will analyze and summarize the effect of KT on improving PLBP. It includes whether KT can improve the pain and lumbar function of PLBP, or it has adverse effects and reactions on pregnant women, then analysis and interpretation of other related issues. It is expected that the results of this study will provide a reference to the method and time of taping for clinical staff, as well as high-quality evidence to resolve the effect of KT on low back pain and provide corresponding guidance for pregnant women with low back pain. It aims to improve the status of low back pain in pregnant women and improve their physical health.
Protocol registration number: PROSPERO CRD42021250373; https://clinicaltrials.gov/.