UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026174 |
|---|---|
| Receipt number | R000030076 |
| Scientific Title | Extracorporeal shockwave therapy in musculoskeletal disorders |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2019/10/03 15:02:24 |
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Basic information
Public title
Extracorporeal shockwave therapy in musculoskeletal disorders
Acronym
Extracorporeal shockwave therapy in musculoskeletal disorders
Scientific Title
Extracorporeal shockwave therapy in musculoskeletal disorders
Scientific Title:Acronym
Extracorporeal shockwave therapy in musculoskeletal disorders
Region
| Japan |
Condition
Condition
enthesopathy
stress fracture
non union
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of extracorporeal shock wave therapy in musculoskeletal disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the pain after the extracorporeal shockwave therapy in enthesopathy, stress fracture and non union.
Key secondary outcomes
The period before making bone union after the extracorporeal shockwave therapy in enthesopathy, stress fracture and non union.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The extracorporeal shockwave was delivered to the tender area in enthesopathy or the fracture area.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We follow the adaptation disease that the International Society for Medical Shockwave Treatment make a recommendation.
Key exclusion criteria
anticoagulant medication,
thrombotic disease,
malignant disorder,
pregnant woman,
The patients who continue receiving cortisone treatment more than six months or the patient who does not pass from the last cortisone injection for six weeks.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Konno |
Organization
Fukushima Medical University School
Division name
Department of Orthopedic Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1276
fortho@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Igari |
Organization
Fukushima Medical University School
Division name
Department of Orthopedic Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1276
Homepage URL
igataka@fmu.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Fukushima Medical University School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Fukushima Medical University School
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
Tel
0245471276
igataka@fmu.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
| 2017 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030076
| 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 |
