UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051369 |
|---|---|
| Receipt number | R000058606 |
| Scientific Title | Effect of precontraction of the transversus abdominis muscle during standing trunk flexion on spinal muscle activity and biomechanics |
| Date of disclosure of the study information | 2023/06/17 |
| Last modified on | 2024/03/30 22:22:51 |
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Basic information
Public title
Effect of precontraction of the transversus abdominis muscle during standing trunk flexion on spinal muscle activity and biomechanics
Acronym
Transversus abdominis preceding contraction test
Scientific Title
Effect of precontraction of the transversus abdominis muscle during standing trunk flexion on spinal muscle activity and biomechanics
Scientific Title:Acronym
Transversus abdominis preceding contraction test
Region
| Japan |
Condition
Condition
Healthy men
person with chronic lower back pain(No medical history)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how the presence or absence of transversus abdominis contraction affects standing trunk flexion range of motion and trunk muscle activity to aid in physical therapy programs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in maximum spinal flexion angle
Changes in EMG waveforms at rest and during exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention 1 No transversus abdominis contraction (washout 1 week) transversus abdominis contraction
Interventions/Control_2
Intervention 2 transversus abdominis contraction (washout 1 week) No transversus abdominis contraction
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Males over 20 years old
Able to perform standing trunk forward bending movements
BMI<30kg/m2
No leg pain of nerve root and cauda equina origin
Key exclusion criteria
Patients with leg pain of nerve root and cauda equina origin
Patients with a history of surgery
Patients with pain so severe that analgesics must be taken internally.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | hiroh |
| Middle name | |
| Last name | matsuse |
Organization
Kurume University Hospital
Division name
Rehabilitation Department
Zip code
830-0011
Address
67 Asahi-cho, Kurume-city, Fukuoka,japan
TEL
0942-35-3311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | natsuru |
| Middle name | |
| Last name | kuchiwaki |
Organization
Kurume University Graduate School of Medicine
Division name
Rehabilitation Biomechanics
Zip code
830-0011
Address
67 Asahi-cho, Kurume-city, Fukuoka,japan
TEL
090-9073-1284
Homepage URL
natsuru726.9.7@gmail.com
Sponsor or person
Institute
Kurume University
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
Kurume University Medical Ethics Committee
Address
67 Asahi-cho, Kurume-shi, Fukuoka, Japan
Tel
0942-31-7200
i_rinri@kurume-u.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 | 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
12
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
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058606
