UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060635 |
|---|---|
| Receipt number | R000068814 |
| Scientific Title | Survey of the frequency, onset, and patient characteristics of phantom limb pain after major limb amputation: a single-center retrospective study |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/09 23:47:01 |
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Basic information
Public title
Survey of the frequency, onset, and patient characteristics of phantom limb pain after major limb amputation: a single-center retrospective study
Acronym
Survey of the frequency, onset, and patient characteristics of phantom limb pain after major limb amputation: a single-center retrospective study
Scientific Title
Survey of the frequency, onset, and patient characteristics of phantom limb pain after major limb amputation: a single-center retrospective study
Scientific Title:Acronym
Survey of the frequency, onset, and patient characteristics of phantom limb pain after major limb amputation: a single-center retrospective study
Region
| Japan |
Condition
Condition
major limb amputation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of phantom limb pain in patients who underwent major limb amputation surgery at our hospital, as well as patient background, onset, treatment, and frequency of referral to our pain clinic.
Basic objectives2
Others
Basic objectives -Others
incidence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and onset of phantom limb pain within one year after major limb amputation
Key secondary outcomes
The causative disease, amputation site, patient background, frequency and timing of referral to a pain clinic in patients who developed phantom limb pain within one year after major limb amputation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years or older who underwent limb amputation proximal to the fingers and toes at our hospital between January 1, 2010 and November 30, 2025, or who underwent traumatic limb amputation proximal to the fingers and toes without replantation.
Key exclusion criteria
1. Patients under the age of 20
2. Other individuals who the principal investigator deems inappropriate to be research subjects (participants)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263372670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-0807
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263372670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
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
Shinshu University School of Medicine Ethics Committee for Research in Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-3099
mdrinri@shinshu-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 | 02 | Month | 10 | 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
186
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 | 12 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. We will investigate, using descriptive statistics, the incidence and timing of onset of phantom limb pain after limb amputation at our institution, as well as the underlying diseases, amputation sites, patient characteristics, and the frequency and timing of referral to the pain clinic.
2. Based on the descriptive results, logistic regression analysis will be performed to identify risk factors associated with the development of phantom limb pain.
Management information
Registered date
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068814
