UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053733 |
|---|---|
| Receipt number | R000061225 |
| Scientific Title | A cross-sectional study of anterior cutaneous nerve entrapment syndrome at an emergency department of a single center in Japan |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2025/02/26 00:02:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A cross-sectional study of anterior cutaneous nerve entrapment syndrome at an emergency department of a single center in Japan
Acronym
A cross-sectional study of anterior cutaneous nerve entrapment syndrome at emergency department in Japan
Scientific Title
A cross-sectional study of anterior cutaneous nerve entrapment syndrome at an emergency department of a single center in Japan
Scientific Title:Acronym
Tama-ACNES-EDO Study: Tama Anterior Cutaneous Nerve Entrapment Syndrome in Emergency Department Observational Study
Region
| Japan |
Condition
Condition
Anterior cutaneous nerve entrapment syndrome (ACNES)
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous studies of anterior cutaneous nerve entrapment syndrome (ACNES) are mostly reported by a few skilled facilities for ACNES in Europe; therefore, pragmatic prevalence, disease characteristics, and medical practice in emergency departments (EDs) at general hospitals in Japan are still unknown. In this research, we conducted a single-center cross-sectional study based on medical records from a community teaching hospital in Japan to investigate the prevalence, clinical characteristics, and diagnostic practice of ACNES in the EDs.
Basic objectives2
Others
Basic objectives -Others
In this research, we conducted a single-center cross-sectional study based on medical records from a community teaching hospital in Japan to investigate the prevalence, clinical characteristics, and diagnostic practice of ACNES in the EDs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Information as follows was collected by reviewing medical records of ED; patient age, sex, year of diagnosis, attending physician who diagnosed, past medical history and comorbidities, history about clinical features of pain (including time duration from symptom onset to presentation, exacerbation by motion or position changes, quality, severity, and location of pain), results of abdominal physical examination (including Carnett's sign, pinch sign, sensory disturbances), modalities conducted to investigate or differentiate a cause of abdominal pain in ED, number of clinics or hospitals visited before the diagnosis was made in the ER (if any), and differential diagnosis attending physical considered. Furthermore, an attempt of follow-up by telephone interview with all eligible patients was conducted to investigate a long-term prognosis for recurrence of ACNES or change of diagnosis after returning from the ED.
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The medical records at TMTMC are all electronic, with a function for performing a full-text search of all patients' records. Using this full-text search function, we extracted cases from the records of all patients who visited the ED between January 1, 2014, and December 31, 2023. These cases contained descriptions of "anterior cutaneous nerve entrapment syndrome" (in both English and Japanese) or "ACNES." Subsequently, each case record was reviewed, and cases meeting all four of the following criteria were identified: 1) Presenting with abdominal pain at the ED, 2) a positive Carnett's sign, 3) effective and prompt pain relief from trigger point injections with local anesthetics, and 4) a final, comprehensive clinical diagnosis of ACNES by the attending physician.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
(+81)42-323-5111
yasuhiro.kano.21@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
(+81)42-323-5111
Homepage URL
yasuhiro.kano.21@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
Tel
(+81)42-323-5111
yasuhiro.kano.21@gmail.com
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
東京都立多摩総合医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.715
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.715
Number of participants that the trial has enrolled
21
Results
Twenty-one patients were included. Their median age was 50 years, 13 (62%) were female, and 11 (52%) had acute-onset pain. Follow-up data were available for 11 patients (52%), seven (64%) of whom had recurrent pain for a median period of 1 week after the index visit. The proportion of ACNES cases among those of abdominal pain was 0.11%.
Results date posted
| 2024 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the entire cohort was 50 years (range: 16-83 years), 13 patients (62%) were female, five patients (24%) had diabetes mellitus, and 11 patients (52%) had acute-onset pain (<1 week) (Tables 1 and 2). Five patients (24%) had been seen at another hospital prior to their ED visit, and on average the patients visited a hospital 2.4 times. Seven (33%), five (24%), and one patient (5%) had a history of abdominal surgery, diabetes mellitus, and current pregnancy, respectively.
Participant flow
Initially, 89 cases described as anterior cutaneous nerve entrapment syndrome or ACNES were identified in the EMR, and 79 cases were reviewed in detail. Of these, 21 cases diagnosed after 2017 were finally included.
Adverse events
None
Outcome measures
The following data were extracted from the EMR: the patients' age, gender, year of diagnosis, diagnosing physician, medical history, comorbidities, clinical features of the pain (including duration from symptom onset to presentation, exacerbation by movement or positional changes, quality, severity, and location), results of abdominal physical examination (including tests for Carnett's sign, pinch sign, and sensory disturbances), tests performed in the ED, and the number of clinics or hospitals visited before the diagnosis was made in the ED.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Review of medical records and telephone follow-up
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061225
