UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053637 |
|---|---|
| Receipt number | R000061217 |
| Scientific Title | Efficacy of Rehabilitation Based on Ultrasound Evaluation for Plantar Pain |
| Date of disclosure of the study information | 2024/02/17 |
| Last modified on | 2024/02/17 11:17:31 |
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Basic information
Public title
Efficacy of Rehabilitation Based on Ultrasound Evaluation for Plantar Pain
Acronym
Efficacy of Rehabilitation Based on Ultrasound Evaluation for Plantar Pain
Scientific Title
Efficacy of Rehabilitation Based on Ultrasound Evaluation for Plantar Pain
Scientific Title:Acronym
Efficacy of Rehabilitation Based on Ultrasound Evaluation for Plantar Pain
Region
| Japan |
Condition
Condition
chronic plantar fasciitis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether physiotherapy based on ultrasound evaluation is an effective treatment for plantar foot pain
Basic objectives2
Others
Basic objectives -Others
To examine whether there is a difference in treatment outcome between general physiotherapy and physiotherapy based on US assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FAAM ADL, FAAM Sports, NRS (pain when walking, morning)
Key secondary outcomes
CSI (central sensitization)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Physical therapy based on ultrasound evaluation
Interventions/Control_2
General Physical Therapy and Extracorporeal Shock Wave Therapy 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are as follows: Patients with plantar pain for at least 3 months and with walking pain in the plantar region.
Key exclusion criteria
Exclusion criteria are a history of ankle or foot surgery due to trauma, a history of fracture, or complications of rheumatism or diabetes mellitus.
Target sample size
42
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
AR-Ex Medical Group
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
明大前整形外科クリニック(東京都)、尾山台整形外科東京関節鏡センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2024 | Year | 02 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
