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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041274
Receipt No. 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 2020/09/07

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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
Email 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
Email ctscwg@gmail.com

Sponsor
Institute Teikyo University
Institute
Department

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
Email 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
2023 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
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.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


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