Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study

UMIN ID: UMIN000056995

Registered date:12/02/2025

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: patients taking corticosteroids
• Date of first enrollment: 2025/03/11
• Target sample size: 452
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: To investigate the incidence of acupuncture-related adverse events in patients taking steroids, particularly infections (Infection and Infestation) classified as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, occurring within 2 weeks after an acupuncture session.
• Secondary Outcome: To investigate procedural complications (Injury and Procedural Complications) and skin disorders (Skin and Subcutaneous Tissue Disorders) in patients taking steroids, based on CTCAE version 5.0, occurring within two weeks after an acupuncture session.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients whose steroid use had already ended at the start of acupuncture treatment. Patients using only topical steroids, transdermal patches, or inhaled steroids. Patients with unknown duration of corticosteroid use Patients with an unknown dosage of corticosteroid use

Related Information

• Primary Sponsor: Saitama Medical University
• Source(s) of Monetary Support: Saitama Medical University