UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062782 |
|---|---|
| Receipt number | R000071876 |
| Scientific Title | Reliability Assessment of a Classification Method for Sites of Maximum Pain After Distal Radius Fracture Surgery Based on Anatomical Landmarks |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 13:42:12 |
* 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
Reliability Assessment of a Classification Method for Sites of Maximum Pain After Distal Radius Fracture Surgery Based on Anatomical Landmarks
Acronym
Reliability Assessment of a Classification Method for Sites of Maximum Pain After Distal Radius Fracture Surgery Based on Anatomical Landmarks
Scientific Title
Reliability Assessment of a Classification Method for Sites of Maximum Pain After Distal Radius Fracture Surgery Based on Anatomical Landmarks
Scientific Title:Acronym
Reliability Assessment of a Classification Method for Sites of Maximum Pain After Distal Radius Fracture Surgery Based on Anatomical Landmarks
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the reliability of a method for classifying the site of maximum pain reported by patients into three categories (radial-sided pain, ulnar-sided pain, and other) based on anatomical landmarks of the wrist.
Basic objectives2
Others
Basic objectives -Others
Reliability study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter-rater reliability (Cohen's kappa coefficient) between two occupational therapists regarding the classification of the site of maximal pain (radial-side pain, ulnar-side pain, or other).
Key secondary outcomes
Intra-rater reliability (Cohen's kappa coefficient) of the classification of the site of maximal pain by a single occupational therapist.
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
| 18 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent postoperative evaluation for distal radius fracture (DRF) at our facility between April 2022 and March 2023 and were able to clearly indicate the site of maximum pain.
Key exclusion criteria
Patients who reported "no pain" during the assessment, or patients for whom it was difficult to identify the site of maximum pain due to factors such as cognitive impairment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
390-8510
Address
Honjo 1-5-2, Matsumoto
TEL
81-0263-33-8600
ai.47324@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
390-8510
Address
Honjo 1-5-2, Matsumoto
TEL
81-0263-33-8600
Homepage URL
ai.47324@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aizawa Hospital Clinical Research Ethics Committee
Address
Honjo 1-5-2, Matsumoto 390-8510, Japan
Tel
81-0263-33-8600
kenkuy@hosp.or.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
| 2026 | Year | 09 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted with the approval of the ethics committee and the consent of the participants; to ensure the objectivity of the assessment, independent, blinded classification was performed during the evaluation of inter-rater and intra-rater reliability.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071876
