Effectiveness of extracorporeal shock wave monotherapy for avascular necrosis of femoral head A systematic review protocol of randomized controlled trial

Background: Previous clinical studies have reported that extracorporeal shock wave (EPSW) monotherapy can effectively treat avascular necrosis of femoral head (ANFH). However, no systematic review has been conducted to assess its effectiveness and safety for patients with ANFH. Therefore, this study will systematically assess the effectiveness and safety of EPSW monotherapy for patients with ANFH. Methods: In this study, the following electronic databases will be searched from their inceptions to the present: Cochrane Library, EMBASE, PUBMED, Cumulative Index to Nursing and Allied Health Literature, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database. This study will include randomized controlled trials for assessing the effectiveness and safety of EPSW monotherapy for patients with ANFH. Two independent authors will perform study selection, data extraction, and methodology assessment. RevMan 5.3 software will be used for statistical analysis. Results: This systematic review will provide latest summary evidence of EPSW monotherapy for patients with ANFH through assessing the outcome measurements. The primary outcome is pain intensity, which can be measured by visual analog scale or relevant measurement tools. The secondary outcomes are functional status of attacked femoral head, as assessed by Western Ontario and McMaster Universities Osteoarthritis Index, or other relevant scales; quality of life, as evaluated by The 36-Item Short Form Health Survey, or related instruments; and adverse events. Conclusion: The results of this study may provide the latest evidence for assessing the effectiveness and safety of EPSW for the treatment of ANFH. Dissemination and ethics: This study does not require ethical approval, because no individual data will be involved in this systematic review. The findings of this study will be published through a peer-reviewed journal. Systematic review registration: PROSPERO CRD42019124665.