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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038499
Receipt No. R000043869
Scientific Title Efficacy of traditional and heating brace for orthopedic disease : A Prospective,Randomized Controlled Trial
Date of disclosure of the study information 2020/12/31
Last modified on 2019/11/05

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Basic information
Public title Efficacy of traditional and heating brace for orthopedic disease : A Prospective,Randomized Controlled Trial
Acronym Efficacy of traditional and heating brace: A Prospective, Randomized Controlled Trial
Scientific Title Efficacy of traditional and heating brace for orthopedic disease : A Prospective,Randomized Controlled Trial
Scientific Title:Acronym Efficacy of traditional and heating brace: A Prospective, Randomized Controlled Trial
Region
Japan

Condition
Condition Orthopedic disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of traditional and heating brace.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes patient satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 treatment with heating brace for 6 to12 months
Interventions/Control_2 treatment with traditional brace for 6 to12 months
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 Patient with persistent pain over 1 month.
Key exclusion criteria Patient with skin trouble.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Suzuki
Middle name
Last name Taku
Organization Aiko Orthopedic Surgery Hospital
Division name Orthopedic Surgery
Zip code 458-0919
Address 1221 Jinmyo, Okehazama, Midoriku, Nagoya
TEL 052-625-1009
Email sutaku49@gmail.com

Public contact
Name of contact person
1st name Suzuki
Middle name
Last name Taku
Organization Aiko Orthopedic Surgery Hospital
Division name Orthopedic Surgery
Zip code 458-0919
Address 1221 Jinmyo, Okehazama, Midoriku, Nagoya
TEL 052-625-1009
Homepage URL
Email sutaku49@gmail.com

Sponsor
Institute Aiko Orthopedic Surgery Hospital
Institute
Department

Funding Source
Organization Phiten
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 IRB Aiko Orthopedic Surgery
Address 1221 Jinmyo, Okehazama, Midoriku, Nagoya
Tel 052-625-1009
Email katsu.59@mc.ccnw.ne.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
2020 Year 12 Month 31 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
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2030 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 05 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043869

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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