UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058819 |
|---|---|
| Receipt number | R000067263 |
| Scientific Title | Correlation between the location of maximum pain after distal radius fracture surgery and treatment outcomes |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/19 16:04:26 |
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Basic information
Public title
Correlation between the location of maximum pain after distal radius fracture surgery and treatment outcomes
Acronym
Correlation between the location of maximum pain after distal radius fracture surgery and treatment outcomes
Scientific Title
Correlation between the location of maximum pain after distal radius fracture surgery and treatment outcomes
Scientific Title:Acronym
Correlation between the location of maximum pain after distal radius fracture surgery and treatment outcomes
Region
| Japan |
Condition
Condition
distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the location of maximum pain after distal radius fracture surgery and to clarify the relationship between the location and intensity of pain and treatment outcomes.
Basic objectives2
Others
Basic objectives -Others
Exploration of factors (predictors) that influence treatment outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-Rated Wrist Evaluation (PRWE)
Key secondary outcomes
Visual Analog Scale (VAS)
The location of maximum pain
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 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The selection criteria for patients are those who have undergone DRF surgery at our hospital.
Key exclusion criteria
Exclusion criteria are multiple trauma, bone disease, dorsal plate fixation, and external fixation.
Target sample size
140
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
| 2025 | Year | 08 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are asked to indicate the location of maximum pain on the day after surgery, at 1 week, 3 weeks, 6 weeks, and 12 weeks postoperatively. The location of pain is then converted into a heat map and classified into ulnar, radial, or other categories.
Pain intensity is assessed using the Visual Analog Scale (VAS).
Treatment outcomes are evaluated using the Patient-Rated Wrist Evaluation (PRWE), and related factors are analyzed using multiple regression analysis, with explanatory variables including age, gender, fracture type (AO classification and presence/absence of ulnar fracture), pain localization, and VAS.
Management information
Registered date
| 2025 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067263
