UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056995 |
|---|---|
| Receipt number | R000065127 |
| Scientific Title | Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study |
| Date of disclosure of the study information | 2025/02/12 |
| Last modified on | 2025/03/11 16:36:23 |
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Basic information
Public title
Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study
Acronym
Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study
Scientific Title
Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study
Scientific Title:Acronym
Incidence of Acupuncture-Related Adverse Events in Patients Taking Corticosteroids: A Retrospective Chart Review Study
Region
| Japan |
Condition
Condition
patients taking corticosteroids
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the incidence of acupuncture-related adverse events in patients taking corticosteroids
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who received acupuncture treatment at the Department of Oriental Medicine, Saitama Medical University Hospital between April 1, 2013, and October 31, 2024, or at the Department of Oriental Medicine, Kawagoe Clinic between April 1, 2020, and October 31, 2024.
2) Patients who were treated with oral or intravenous steroids. The eligible steroid formulations include hydrocortisone, cortisone, prednisolone, methylprednisolone, triamcinolone, dexamethasone, and betamethasone.
Key exclusion 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
Target sample size
452
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Murahashi |
Organization
Saitama Medical University Hospital
Division name
Department of Oriental Medicine
Zip code
350-0495
Address
38 Moroyama Hongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
049-276-1193
murahashi.masaki@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Murahashi |
Organization
Saitama Medical University Hospital
Division name
Department of Oriental Medicine
Zip code
350-0495
Address
38 Moroyama Hongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
049-276-1193
Homepage URL
murahashi.masaki@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital, Hospital COI Management Committee Secretariat
Address
Saitama Medical University Hospital Clinical Research Center
Tel
049-276-1354
murahashi.masaki@1972.saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Setting: Two medical institutions in Japan, a hospital and a clinic. The objective is to investigate the incidence of acupuncture-related adverse events in patients taking steroids. Adverse events are defined according to CTCAE version 5.0, including infections (Infection and Infestation), procedural complications (Injury, Poisoning, and Procedural Complications), and skin disorders (Skin and Subcutaneous Tissue Disorders). These events must occur within two weeks after acupuncture treatment, require consultation with another department, and be diagnosed and treated by a physician.
If an adverse event occurred, it was categorized by CTCAE grade, and logistic regression analysis was performed to identify associated factors. If the incidence of adverse events was low, Firths logistic regression model was used
Management information
Registered date
| 2025 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065127
