UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032380 |
|---|---|
| Receipt number | R000036923 |
| Scientific Title | The relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors-A surface electromyogram study |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2021/10/27 18:34:39 |
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Basic information
Public title
The relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors-A surface electromyogram study
Acronym
Muscle activity at the movement of chronic low back pain patients
Scientific Title
The relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors-A surface electromyogram study
Scientific Title:Acronym
Muscle activity at the movement of chronic low back pain patients
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activation of surface EMG (first time and after 1 month)
Key secondary outcomes
Numerical Rating Scale
Short-Form McGill Pain Questionnaire 2
Tampa Scale for Kinesiophobia-11
Pain Catastrophizing Scale-4
Hospital Anxiety and Depression Scale
The Fremantle Back Awareness Questionnaire
Central Sensitization Inventory
Pain Self Efficacy Questionnaire-2
Roland-Morris Disability Questionnaire
EuroQol 5-dimension
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Chronic low back pain
Key exclusion criteria
Dementia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Shigetoh |
Organization
Graduate School of Kio University
Division name
Health Science
Zip code
635-0832
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL
0745-54-1601
hayato.pt1121@gmail.com
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Shigetoh |
Organization
Graduate School of Kio University
Division name
Health Science
Zip code
635-0832
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL
090-7147-8059
Homepage URL
hayato.pt1121@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Graduate School of Kio University
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
Tel
0745-54-1601
hayato.pt1121@gmail.com
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 | 25 | 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
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants do trunk flextion and extension movement task. Experimenter assesses muscle activity at the movement by a surface electromyogram. Also, participants answer questionnaire that related to pain.
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036923
| 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 |
