UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053535 |
|---|---|
| Receipt number | R000061096 |
| Scientific Title | Effects of extracorporeal shock wave therapy on plantar tendonitis. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/02/04 16:53:41 |
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Basic information
Public title
Effects of extracorporeal shock wave therapy on plantar tendonitis.
Acronym
Effects of extracorporeal shock wave therapy on plantar tendonitis.
Scientific Title
Effects of extracorporeal shock wave therapy on plantar tendonitis.
Scientific Title:Acronym
Effects of extracorporeal shock wave therapy on plantar tendonitis.
Region
| Japan |
Condition
Condition
plantar tendinitis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effects of extracorporeal shock wave therapy on functional aspects such as gait and muscle strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain, walking movements and muscle strength before and after intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
extracorporeal shock wave therapy
Interventions/Control_2
placebo
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with plantar tendonitis
Key exclusion criteria
participants who have a tumor, obvious lumbar herniation, lumbar spinal canal stenosis, infections, musculoskeletal disorder, sciatic nerve compression and pain, sensory impairment, decreased muscle strength and reflex.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo university
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
0754912141
m-wachi@bukkyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Wachi |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo Univertity
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
0754912141
Homepage URL
m-wachi@bukkyo-u.ac.jp
Sponsor or person
Institute
Furu clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
Kanazawa Orthopaedic & Sports Medicine Clinic
Address
881 Ono, Ritto, Shiga
Tel
0775530007
k.riha-workshop@kanazawaseikei.or.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
「布留クリニック（滋賀県）」
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
| 2024 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061096
