UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046875 |
|---|---|
| Receipt number | R000053480 |
| Scientific Title | Factors Associated with Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2023/08/18 18:35:31 |
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Basic information
Public title
Factors Associated with Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain
Acronym
Factors Associated with Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain
Scientific Title
Factors Associated with Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain
Scientific Title:Acronym
Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain
Region
| Japan |
Condition
Condition
Factors Associated with Posterior Tibial Artery Blood Flow Velocity in Plantar Heel Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the posterior tibial artery blood flow velocity in patients with plantar pain.
Basic objectives2
Others
Basic objectives -Others
To clarify the cutoff value of posterior tibial artery blood flow velocity in healthy subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Posterior Tibial Artery Blood Flow Velocity between Plantar Pain Group and Normal Group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Plantar Heel pain group
Interventions/Control_2
Control group
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
| 10 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Diagnosis of plantar aponeurosis
2)Study on consent
Key exclusion criteria
1)Symptoms other than plantar pain
2)The presence of inflammation in other parts of the body
3)Consent is obtained
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Faculty of Comprehensive Rehabilitation Studies, Department of Physical Therapy
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ku, Osaka
TEL
06-6616-6911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Kaneko |
Organization
Meidaimae Orthopedic Clinic
Division name
Rehabilitation Medicine
Zip code
156-0043
Address
1-38-25, Matsubara Setagaya-ku, Tokyo
TEL
03-6304-7681
Homepage URL
kaneko-fumiya@ar-ex.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Morinomiya University of Medical Science Ethics Review Committee
Address
1-26-16, Minami-Minato-Kita, Suminoe-ku, Osaka-shi, Osaka
Tel
06-6616-6911
soumu@morinomiya-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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
23
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053480
