Efficacy and Safety of Shi Cervical Rotational Manipulation inPatients With Atlantoaxial Joint Subluxation:Protocol for aRandomized Controlled Trial

Background: The clinical diagnosis of atlantoaxial joint subluxation (AJS) in traditional Chinese medicine (TCM) is characterizedby an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompaniedby symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi cervical rotational manipulation (SCRM)is a commonly employed TCM manual therapy for treating this condition. Nevertheless, there is a lack of evidence-based medicalinformation regarding the clinical efficacy and safety of this technique.Objective: The principal aim of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS.Methods: This study is a prospective randomized controlled clinical trial that will be conducted at a single center and that hasa follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS will be recruited from outpatient and inpatient clinicsat Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients will be randomly assignedto either the experimental group (SCRM) or the comparison group (basic cervical manipulation [BCM]). Treatment sessionsconsisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. Clinical monitoring indicators includethe presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination findingsusing cervical computed tomography, degree of neck pain measured by a visual analog scale (VAS), cervical range of motionassessed through cervical mobility measurement, degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version(VSS-C), and adverse events that may occur during the follow-up period. The time points for data collection and follow-up arebaseline and postintervention (weeks 4, 8, 12, 16, 20, and 24).Results: This paper presents an overview of the reasoning and structure of a prospective randomized controlled trial with theobjective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinicalsymptoms, neck pain severity, and vertigo severity and evaluating changes in cervical imaging findings. Recruitment was startedin March 2023. By the end of May 2024, 76 patients were included in this project. The last follow-up data are predicted to becollected by the end of February 2025.Conclusions: This investigation will yield dependable evidence regarding the efficacy and safety of SCRM in patients withAJS.Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068510;https://www.chictr.org.cn/showprojEN.html?proj=186883International Registered Report Identifier (IRRID): DERR1-10.2196/57865