UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038499 |
|---|---|
| Receipt number | 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 | 2023/11/29 18:49:40 |
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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
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
sutaku49@gmail.com
Sponsor or person
Institute
Aiko Orthopedic Surgery Hospital
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 25 | Day |
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
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043869
