UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041274 |
|---|---|
| Receipt number | R000046490 |
| Scientific Title | Multicenter study for diagnostic criteria for carpal tunnel syndrome: differentiation from cervical spondylosis |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/08/04 15:19:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter study for diagnostic criteria for carpal tunnel syndrome: differentiation from cervical spondylosis
Acronym
Multicenter study for diagnostic criteria for carpal tunnel syndrome
Scientific Title
Multicenter study for diagnostic criteria for carpal tunnel syndrome: differentiation from cervical spondylosis
Scientific Title:Acronym
Multicenter study for diagnostic criteria for carpal tunnel syndrome
Region
| Japan |
Condition
Condition
Carpal tunnel syndrome, Cervical spondylosis
Classification by specialty
| Neurology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop diagnostic criteria for carpal tunnel syndrome
Basic objectives2
Others
Basic objectives -Others
diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of carpal tunnel syndrome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Carpal tunnel syndrome: Patients with hand symptoms who are suspected to have carpal tunnel syndrome and who have not been treated for the symptoms. In bilaterally affected patients, the more severe hand is included.
Cervical spondylosis: Patients with hand symptoms in the median nerve region and diagnosed with cervical spondylosis who have not been treated for the symptoms.
Healthy control: Subjects with no hand symptoms and no history of diseases affecting the hands or diabetes mellitus. Non-dominant hand is included. We will enroll a healthy subject group that is age-matched to patients with carpal tunnel syndrome and a reproducibility study group that is not age-matched, with some overlap.
Key exclusion criteria
Secondary carpal tunnel syndrome, history of diseases affecting the hands, diabetic neuropathy, severe diabetes mellitus, rheumatoid arthritis, hypothyroidism, hyperthyroidism, dialysis, severe renal failure, or otherwise deemed inappropriate.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Sonoo |
Organization
Teikyo University School of Medicine
Division name
Department of Neurology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
+81-3-3964-1211
ctscwg@gmail.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Sonoo |
Organization
Teikyo University School of Medicine
Division name
Department of Neurology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
+81-3-3964-1211
Homepage URL
ctscwg@gmail.com
Sponsor or person
Institute
Teikyo 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
Department of Neurology, Chiba University Graduate School of Medicine
Keio University Hospital Clinical and Translational Research Center
Department of Orthopaedic Surgery, Yokohama Rosai Hospital
Department of Orthopaedic Surgery, National Hospital Organization Kasumigaura Medical Center
Department of Orthopedic and Hand surgery, Sen-en Rifu Hospital
Department of Rehabilitation Medicine, Tokai University School of Medicine
Department of Orthopedics, Tokai University School of Medicine
Department of Orthopaedic surgery, Tokyo Metropolitan Hiroo Hospital
The Hand Surgery Center, Sakura Orthopaedic Hospital
Department of Orthopaedic Surgery, Tokyo Metropolitan Geriatric Hospital
Department of Neurology, Tokyo Metropolitan Geriatric Hospital
Department of Neurology, Kanazawa Medical University
Department of Orthopaedic Surgery, University of Occupational and Environmental Health
Department of Rehabilitation Medicine University of Occupational and Environmental Health
Neurology Clinic Chiba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
+81-3-3964-7256
turb-office@teikyo-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
帝京大学医学部附属病院（東京都）
千葉大学医学部附属病院（千葉県）
慶應義塾大学（東京都）
横浜労災病院（神奈川県）
霞ヶ浦医療センター（茨城県）
筑波大学附属病院（茨城県）
東北ろうさい病院（宮城県）
仙塩利府病院（宮城県）
東海大学医学部付属病院（神奈川県）
東京都立広尾病院（東京都）
佐倉整形外科病院（千葉県）
東京都健康長寿医療センター（東京都）
金沢医科大学病院（石川県）
産業医科大学病院（福岡県）
脳神経内科千葉（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case-control study
Management information
Registered date
| 2020 | Year | 08 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
