UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056897 |
|---|---|
| Receipt number | R000065031 |
| Scientific Title | Involvement of Oxidative Stress in Frozen Shoulder |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/01/17 07:08:54 |
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Basic information
Public title
Involvement of Oxidative Stress in Frozen Shoulder
Acronym
Involvement of Oxidative Stress in Frozen Shoulder
Scientific Title
Involvement of Oxidative Stress in Frozen Shoulder
Scientific Title:Acronym
Involvement of Oxidative Stress in Frozen Shoulder
Region
| Japan |
Condition
Condition
Frozen Shoulder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Glycation stress is implicated in frozen shoulder (FS). The expressions of advanced glycation end-products (AGEs) and their receptors (RAGE) induce oxidative stress. However, the relationship between FS and oxidative stress remains unclear. This study aimed to determine whether oxidative stress and the antioxidant enzymes, such as nicotinamide adenine dinucleotide phosphate oxidase (NOX), superoxide dismutase (SOD), and peroxiredoxin (PRDX), are involved in FS.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathogenesis of frozen shoulder
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological evaluation (The total degeneration score), DHE staining, SOD activity, gene expression analysis (SOD1, SOD2, SOD3, PRDX5, MMP1, MMP3, MMP13, GAPDH) by quantitative real-time polymerase chain reaction (RT-PCR) Gene expression analysis by RT-PCR
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
| Not applicable |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
At older ages, oxidative stress could be involved.
Key exclusion criteria
Diabetes and a history of smoking.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Itoigawa |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
0473533111
h-tsurukami@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Itoigawa |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
0473533111
Homepage URL
h-tsurukami@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
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
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
Tel
0473533111
h-tsurukami@juntendo.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 | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 02 | Month | 01 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065031
