RESUMEN
BACKGROUND: Pharmacoacupuncture (PA) is an alternative injection therapy for a broad range of conditions. This meta-analysis evaluates the effectiveness and safety of PA in treating frozen shoulder (FS) and aims to standardise PA characteristics in clinical practice. METHODS: Randomized controlled trials (RCTs) assessing PA for FS were systematically reviewed from seven electronic databases up to August 31, 2023. Outcomes measured included the visual analogue scale (VAS) or numerical rating scale (NRS), effective rate, Constant-Murley Score (CMS), Shoulder Pain and Disability Index (SPADI), ROM, quality of life (QoL), and adverse events. Data analysis was conducted using RevMan 5.3, with the risk of bias in each trial evaluated using Cochrane's risk of bias tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool assessed the quality of evidence. RESULTS: Thirteen RCTs involving 1034 patients met the inclusion criteria, with eleven RCTs and 872 patients included in the meta-analysis. PA showed low-quality evidence of improvement in VAS, effective rate, CMS Total, and CMS Pain. Moderate-quality evidence indicated improvement in CMS ADL and CMS Mobility. PA was effective in four SF-36 subscales: physical function, social role function, mental health, and emotional role function. No significant difference in CMS strength was observed. One trial reported mild anaphylaxis reaction to bee venom as an adverse event. CONCLUSION: PA may offer potential benefits as an alternative injection therapy for FS patients. Further well-designed RCTs with rigorous methodology are required to substantiate its therapeutic efficacy and clinical utility. REGISTRATION: PROSPERO (CRD42023445708).
RESUMEN
Objectives: Frozen shoulder (FS) is one of the most challenging shoulder disorders for patients and clinicians. Its symptoms mainly include any combination of stiffness, nocturnal pain, and limitation of active and passive glenohumeral joint movement. Conventional treatment options for FS are physical therapy, nonsteroidal anti-inflammatory drugs, injection therapy, and arthroscopic capsular release, but adverse and limited effects continue to present problems. As a result, pharmacoacupuncture (PA) is getting attention as an alternative therapy for patients with FS. PA is a new form of acupuncture treatment in traditional Korean medicine (TKM) that is mainly used for musculoskeletal diseases. It has similarity and specificity compared to corticosteroid injection and hydrodilatation, making it a potential alternative injection therapy for FS. However, no systematic reviews investigating the utilization of PA for FS have been published. Therefore, this review aims to standardize the clinical use of PA for FS and validate its therapeutic effect. Methods: The protocol was registered in Prospero (CRD42023445708) on 18 July 2023. Until Aug. 31, 2023, seven electronic databases will be searched for randomized controlled trials of PA for FS. Authors will be contacted, and manual searches will also be performed. Two reviewers will independently screen and collect data from retrieved articles according to predefined criteria. The primary outcome will be pain intensity, and secondary outcomes will be effective rate, Constant-Murley Score, Shoulder Pain and Disability Index, range of motion, quality of life, and adverse events. Bias and quality of the included trials will be assessed using the Cochrane handbook's risk-of-bias tool for randomized trials. Meta analyses will be conducted using Review Manager V.5.3 software. GRADE will be used to evaluate the level of evidence for each outcome. Results: This systematic review and meta-analysis will be conducted following PRISMA statement. The results will be published in a peer-reviewed journal. Conclusion: This review will provide scientific evidence to support health insurance policy as well as the standardization of PA in clinical practice.