UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060423 |
|---|---|
| Receipt number | R000069123 |
| Scientific Title | A Prospective Multicenter Study on Treatment Outcomes and Surgical Indications for Idiopathic Anterior and Posterior Interosseous Nerve Palsy |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 14:03:09 |
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Basic information
Public title
A Study to Investigate Treatment Methods and Recovery in Anterior and Posterior Interosseous Nerve Palsy
Acronym
Treatment and Recovery Study of Anterior and Posterior Interosseous Nerve Palsy
Scientific Title
A Prospective Multicenter Study on Treatment Outcomes and Surgical Indications for Idiopathic Anterior and Posterior Interosseous Nerve Palsy
Scientific Title:Acronym
Idiopathic AIN/PIN Prospective Multicenter Study
Region
| Japan |
Condition
Condition
Idiopathic Anterior and Posterior Interosseous Nerve Palsy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate the outcomes of conservative treatment and interfascicular neurolysis in patients with idiopathic anterior and posterior interosseous nerve palsy across multiple centers, and to clarify the association between hourglass-like nerve constriction observed on ultrasonography and functional recovery.
This study aims to identify clinically useful indicators for treatment selection and prognostic prediction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between hourglass-like nerve constriction evaluated by ultrasonography (presence, location, and severity) and functional outcome at the final follow-up, assessed by muscle strength grading (MMT).
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
Patients aged 15 years or older who were diagnosed with anterior interosseous nerve palsy or posterior interosseous nerve palsy within 6 months of symptom onset and who provided written informed consent.
Key exclusion criteria
Patients with nerve palsy of a clearly identifiable cause, such as trauma, surgery, or tumor, and patients judged by the investigators to be unsuitable for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Nagoya University Hospital
Division name
Department of Hand Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2965
yamamoto.michiro.e5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yotaro |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University Hospital
Division name
Department of Hand Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2965
Homepage URL
yamada.youtarou.h4@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya 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
Nagoya University Clinical Research Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-744-2423
ethics@med.nagoya-u.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
| 2026 | Year | 01 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2034 | 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 is a prospective multicenter observational study, and no treatment allocation or research-driven intervention will be performed. All treatments, including conservative management or interfascicular neurolysis, will be selected solely based on the attending physician's clinical judgment as part of routine clinical practice.
Clinical data and examination findings obtained during routine care will be prospectively collected, and the association between ultrasonographic nerve constriction and functional outcomes will be analyzed. No additional examinations or treatments will be required for research purposes, and participation in this study will not affect the frequency or content of routine clinical visits.
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069123
