UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057159 |
|---|---|
| Receipt number | R000065339 |
| Scientific Title | The Characteristics of Patients with Shoulder Joint Disorders Undergoing Rehabilitation at Our Clinic |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/27 20:29:38 |
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Basic information
Public title
The Characteristics of Patients with Shoulder Joint Disorders Undergoing Rehabilitation at Our Clinic
Acronym
The Characteristics of Patients with Shoulder Joint Disorders Undergoing Rehabilitation at Our Clinic
Scientific Title
The Characteristics of Patients with Shoulder Joint Disorders Undergoing Rehabilitation at Our Clinic
Scientific Title:Acronym
The Characteristics of Patients with Shoulder Joint Disorders Undergoing Rehabilitation at Our Clinic
Region
| Japan |
Condition
Condition
shoulder impingement syndrome, shoulder contracture, periarthritis of the shoulder, calcific tendinitis of the shoulder, rotator cuff injury of the shoulder, rotator cuff tear of the shoulder, unstable shoulder joint, osteoarthritis of the shoulder, adhesive capsulitis of the shoulder, traumatic arthritis of the shoulder, and rheumatoid
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate at what point in time and to what extent recovery can be expected using indicators such as joint range of motion and level of daily living, and to analyze factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic Information, Presence of Rotator Cuff Tear and Calcification, Treatment Plan (No Surgery Planned, Under Consideration, Future Plans), Presence of Intra-Articular Injections in Recent Examinations, Range of Motion, Muscle Strength, Shoulder Pain and Disability Index (SPADI), Pain Assessment (Visual Analog Scale - VAS).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases diagnosed with shoulder impingement syndrome, adhesive capsulitis, frozen shoulder, calcific tendinitis of the shoulder, rotator cuff injury, rotator cuff tear, shoulder instability, osteoarthritis of the shoulder, adhesive shoulder capsulitis, traumatic shoulder arthritis, and rheumatoid arthritis at our clinic.
Key exclusion criteria
Individuals with fractures around the shoulder joint or shoulder dislocation.Individuals who underwent surgery based on the aforementioned diagnoses.Individuals who received rehabilitation at other facilities for the aforementioned diagnoses.Individuals who expressed refusal to participate in this study through information disclosure documents.Individuals deemed unsuitable by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Kikuchi |
Organization
Saitama Medical University Kawagoe Clinic
Division name
Department of Rehabilitation
Zip code
350-1123
Address
21 7 Wakita Honcho, Kawagoe City, Saitama Prefecturem, Japan.
TEL
049-238-8111
y.kikuike1009@gmail.com
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Kikuchi |
Organization
Saitama Medical University Kawagoe Clinic
Division name
Department of Rehabilitation
Zip code
350-1123
Address
21 7 Wakita Honcho, Kawagoe City, Saitama Prefecturem, Japan.
TEL
049-238-8111
Homepage URL
y.kikuike1009@gmail.com
Sponsor or person
Institute
Saitama Medical University Kawagoe Clinic
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
Saitama medical center ethics committee
Address
1981 Kamoda, Kawagoe, Saitama, Japan.
Tel
049-228-3902
smcrinri@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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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
retrospective observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065339
