UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059008 |
|---|---|
| Receipt number | R000067485 |
| Scientific Title | Verification of the Effects of Concurrent Low Back Pain in Diabetic Patients on Muscle Brightness and Motor Function of the Lumbar Multifidus Muscles |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/05 17:09:20 |
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Basic information
Public title
Verification of the Effects of Concurrent Low Back Pain in Diabetic Patients on Muscle Brightness and Motor Function of the Lumbar Multifidus Muscles
Acronym
Verification of the Effects of Concurrent Low Back Pain in Diabetic Patients on Muscle Brightness and Motor Function of the Lumbar Multifidus Muscles
Scientific Title
Verification of the Effects of Concurrent Low Back Pain in Diabetic Patients on Muscle Brightness and Motor Function of the Lumbar Multifidus Muscles
Scientific Title:Acronym
Verification of the Effects of Concurrent Low Back Pain in Diabetic Patients on Muscle Brightness and Motor Function of the Lumbar Multifidus Muscles
Region
| Japan |
Condition
Condition
Diabetes patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of concomitant low back pain in diabetic patients on the muscle brightness and motor function of the lumbar multifidus muscles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle Brightness Evaluation of the Lumbar Multifidus Muscles, Short Physical Performance Battery
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older diagnosed with type 1 or type 2 diabetes
Key exclusion criteria
Individuals experiencing pain that interferes with daily life, those with typical physical disabilities such as cerebrovascular disorders or rheumatoid arthritis, individuals with a history of fractures in the lumbar region or lower limbs, pregnant individuals, and those with pacemakers are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Nishimura |
Organization
Nanto Municipal Hospital
Division name
Department of Community Rehabilitation
Zip code
932-0211
Address
938 Inami, Nanto City, Toyama
TEL
0763-82-1475
t-nishimura@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Nishimura |
Organization
Nanto Municipal Hospital
Division name
Department of Community Rehabilitation
Zip code
0763-82-1475
Address
938 Inami, Nanto City, Toyama
TEL
0763-82-1475
Homepage URL
t-nishimura@hokuriku-u.ac.jp
Sponsor or person
Institute
Nanto Municipal Hospital
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
Nanri Municipal Hospital Medical Ethics Committee
Address
938 Inami, Nanto City, Toyama
Tel
0763-82-1475
shiminhp@city.nanto.lg.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 | 09 | Month | 05 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the effects of concomitant low back pain in diabetic patients on the muscle brightness and motor function of the lumbar multifidus muscles.
Management information
Registered date
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067485
