Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

UNSTRUCTURED Background： The clinical diagnosis of atlantoaxial joint subluxation (AJS) in Traditional Chinese Medicine (TCM) is characterized by an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompanied by symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi's cervical rotational manipulation (SCRM) is a commonly employed TCM manual therapy for the treatment of this condition. Nevertheless, there is a lack of evidence-based medical research regarding the clinical efficacy and safety assessment of this technique. Therefore, the principal objective of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS. Methods/design: This study is a prospective, randomized controlled clinical trial conducted at a single center, with a follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS were recruited from outpatient and inpatient clinics at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients were randomly assigned to either the experimental group (SCRM) or the comparison group (basic cervical manipulation, BCM). Treatment sessions consisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. The participants will undergo treatment sessions with SCRM or BCM twice a week for a duration of 4 weeks. Clinical monitoring indicators encompass the presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination using cervical CT, the degree of neck pain measured by the Visual Analog Scale (VAS), cervical range of motion assessed through cervical mobility measurement, the degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version (VSS-C), and any adverse events that may occur during the entire follow-up period. The time points for data collection and follow-up occurred at baseline and after the intervention, specifically during the 4th, 8th, 12th, 16th, 20th and 24th week. Discussion: This paper presents an overview of the reasoning and structure of a prospective, randomized controlled trial with the objective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinical symptoms, severity of neck pain, severity of vertigo, and changes in cervical imaging. If this study proves successful, it will offer trustworthy evidence regarding the efficacy and safety of SCRM for patients with AJS. Trial registration: China Registered Clinical Trial Registration Center ChiCTR2300068510. Registration on 21 February 2023.