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

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

ABSTRACT

In this study, we aim to evaluate the effectiveness and safety of Shi cervical rotational manipulation (SCRM) in patients diagnosed with atlantoaxial joint subluxation (AJS). SCRM is a traditional Chinese medicine (TCM) manual therapy commonly used to address this condition. We will conduct a prospective randomized controlled clinical trial at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. The trial will involve 96 AJS patients who will be randomly assigned to receive either SCRM or basic cervical manipulation (BCM) over a 4-week treatment period, with a follow-up duration of 24 weeks. The study will assess clinical symptoms, neck pain severity, vertigo severity, cervical imaging findings, and the occurrence of any adverse events during the follow-up period.

REASONS AND STRUCTURE OF THE STUDY

This paper provides an overview of our study, which aims to investigate the efficacy and safety of SCRM in AJS patients by assessing improvements in clinical symptoms, neck pain severity, vertigo severity, and changes in cervical imaging findings. Recruitment began in March 2023, and by May 2024, 76 patients had been included. The last follow-up data are anticipated to be collected by February 2025.

CONCLUSION

This investigation will provide reliable evidence regarding the efficacy and safety of SCRM in AJS patients.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2300068510; More information.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/57865

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