UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052820 |
|---|---|
| Receipt number | R000060281 |
| Scientific Title | Factors Affecting the Analgesic Effect of Radial Pressure Wave Therapy in Plantar Fasciitis |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/10/21 20:36:03 |
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Basic information
Public title
Factors Affecting the Analgesic Effect of Radial Pressure Wave Therapy in Plantar Fasciitis
Acronym
Factors Affecting the Analgesic Effect of Radial Pressure Wave Therapy in Plantar Fasciitis
Scientific Title
Factors Affecting the Analgesic Effect of Radial Pressure Wave Therapy in Plantar Fasciitis
Scientific Title:Acronym
Factors Affecting the Analgesic Effect of Radial Pressure Wave Therapy in Plantar Fasciitis
Region
| Japan |
Condition
Condition
Plantar Fasciitis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors affecting the analgesic effect obtained in patients treated with radial pressure wave therapy for plantar fasciitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative analgesic effect (improvement rate from the Visual Analogue Scale {VAS} before the first intervention to the VAS before the final intervention)
Key secondary outcomes
Sex, age, duration of illness, radiation intensity, number of interventions, immediate pain relief (improvement rate from VAS before first intervention to VAS before second intervention)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case of plantar fasciitis treated with radial pressure wave therapy
Key exclusion criteria
There is a finding of fracture.
Infection.
Swelling in the affected area.
Diagnosed with neurological disease.
Previous shock wave therapy or surgery.
The decline in cognitive function is significant, and the purpose of this study cannot be understood.
The cumulative analgesic effect cannot be tracked because the number of interventions is three or less.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | MORISHITA |
Organization
Graduate School of Health Sciences
Division name
Graduate School of Health Sciences
Zip code
283-8555
Address
1, Gumyo, Togane-shi, Chiba, Japan
TEL
0475-53-2225
morishita@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | SEZAKI |
Organization
Okutenjin Shiraishi Clinic Orthopedics and Rehabilitation Department
Division name
Department of Rehabilitation
Zip code
569-1118
Address
2-24-1 Okutenjin, Takatsuki, Osaka, Japan
TEL
072-668-1107
Homepage URL
mh23-002@jiu.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board for Research Involving Human Subjects of Josai International University
Address
1, Gumyo, Togane-shi, Chiba, Japan
Tel
0475-55-7832
research-c@jiu.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
| 2024 | Year | 11 | Month | 20 | 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
50
Results
Multiple regression analysis was conducted with cumulative analgesic effect as the dependent variable and sex, age, duration of illness, irradiation intensity, number of interventions, and immediate analgesic effect as the independent variables. As a result, immediate analgesic effect was selected.
Results date posted
| 2024 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Cumulative analgesic effect (improvement rate from VAS before first intervention to VAS before final intervention)
Immediate analgesic effect (improvement rate from VAS before first intervention to VAS before second intervention)
Sex
Age
Duration of illness
Radiation intensity
Number of interventions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060281
