UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057521 |
|---|---|
| Receipt number | R000065709 |
| Scientific Title | The effect of the basic posture on tissue hardness of the posterior sacroiliac ligament |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2025/04/04 17:49:50 |
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Basic information
Public title
Relationship between basic posture and tissue hardness of the posterior sacroiliac ligament
Acronym
Relationship between basic posture and tissue hardness of the posterior sacroiliac ligament
Scientific Title
The effect of the basic posture on tissue hardness of the posterior sacroiliac ligament
Scientific Title:Acronym
The effect of the basic posture on tissue hardness of the posterior sacroiliac ligament
Region
| Japan |
Condition
Condition
Sacroiliac joint pain and healthy individual
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the tissue hardness of the posterior sacroiliac ligament using shear wave elastography in various daily living posture and different contraction patterns of the abdominal muscles in subjects with sacroiliac joint pain and healthy individuals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue hardness of the posterior sacroiliac ligament
Key secondary outcomes
Sacroiliac joint pain, hip range of motion, hip abduction strength, sacroiliac joint special test, ADL score
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
| 46 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unilateral sacroiliac joint pain that allows prone, lateral, sitting, and standing positions/healthy adults
Key exclusion criteria
Those who have difficulty with daily living activities other than sacroiliac joint pain, those who have pain and neurological symptoms other than sacroiliac joint pain, those who have had surgery for orthopedic diseases, those who have a history of neuromuscular disease, cerebrovascular disease, or diabetes, those with cognitive impairment that makes it difficult to understand the experiment, and those who have difficulty going to the hospital alone
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Medical and Health Care
Zip code
350-0436
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
yokubo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Medical and Health Care
Zip code
350-0436
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
Homepage URL
yokubo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Non
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
Saitama Medical University
Address
38, Morohongo, Moroyama-machi, Saitama
Tel
0492762143
rinri@saitama-med.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
| 2025 | Year | 04 | Month | 04 | 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 | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065709
