UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051339 |
|---|---|
| Receipt number | R000058566 |
| Scientific Title | Study of the usefulness of the STarT back screening tool to predict the effect of acupuncture treatment |
| Date of disclosure of the study information | 2023/06/14 |
| Last modified on | 2023/06/14 10:55:49 |
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Basic information
Public title
Study of the usefulness of the STarT back screening tool to predict the effect of acupuncture treatment
Acronym
Study of the usefulness of the STarT back screening tool to predict the effect of acupuncture treatment
Scientific Title
Study of the usefulness of the STarT back screening tool to predict the effect of acupuncture treatment
Scientific Title:Acronym
Study of the usefulness of the STarT back screening tool to predict the effect of acupuncture treatment
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of STarT back screening tool in acupuncture treatment for patients with low back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of visual analogue scale for low back pain
Key secondary outcomes
STarT back screening tool
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
Acupuncture for 4 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pain in the lower back experienced in the last 4 weeks that lasted for more than 1 day
Key exclusion criteria
Those who already have entered another clinical trials
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kondo |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Science
Zip code
305-8521
Address
4-12-7,Kasuga, Tsukuba, Ibaraki, Japan
TEL
029-852-2890
kondo0207@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Matsuda |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
305-8572
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-2111
Homepage URL
s2130327@u.tsuuba.ac.jp
Sponsor or person
Institute
sukuba University of Technology, Faculty of Health Science
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology, Faculty of Health Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology, Faculty of Health Science
Address
4-12-7,Kasuga, Tsukuba, Ibaraki, Japan
Tel
029-852-2890
sayuzawa@k.tsukuba-tech.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
| 2023 | Year | 06 | Month | 14 | 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
71
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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058566
