UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029235 |
|---|---|
| Receipt number | R000033412 |
| Scientific Title | A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/09/21 17:33:15 |
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Basic information
Public title
A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Acronym
A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Scientific Title
A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Scientific Title:Acronym
A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Region
| Japan |
Condition
Condition
Lumbar Spondylolysis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the treatment effect and safety of low-intensity pulsed ultrasound on patients with lumbar spondylolysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bony fusion rate, Duration of the treatment period, Complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low-intensity pulsed ultrasound
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
| 5 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Progressive-stage spondylolysis at the first presentation, Non-union after surgery at 6 months' follow-up.
Key exclusion criteria
Patients obtained with no agreement, patients who do not continue the treatment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Sairyo |
Organization
Tokushima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
Kuramoto 3-18-15, Tokushima city
TEL
0886337240
sairyokun@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Sakai |
Organization
Tokushima University
Division name
Department of Orthopaedic Surgery
Zip code
Address
Kuramoto 3-18-15, Tokushima city
TEL
0886337240
Homepage URL
norinori@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Sigmax Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | 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
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2017 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033412
