UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038283 |
|---|---|
| Receipt number | R000043637 |
| Scientific Title | Relationship between pain and changes of paravertebral muscle and its surrounding connective tissue in patients with low back pain |
| Date of disclosure of the study information | 2019/10/12 |
| Last modified on | 2019/10/12 17:20:12 |
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Basic information
Public title
Relationship between pain and changes of paravertebral muscle and its surrounding connective tissue in patients with low back pain
Acronym
LBP-Study
Scientific Title
Relationship between pain and changes of paravertebral muscle and its surrounding connective tissue in patients with low back pain
Scientific Title:Acronym
LBP-Study
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating how the changes of paravertebral muscle and its surrounding connective tissue affects for the strength and quality of pain in patients with low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound Images of paravertebral muscle and its surrounding connective tissue thickness and echogenicity
Key secondary outcomes
Short-From McGill Pain Questionnaire and Pain DETECT Questionnaire
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Two pain questionnaires, Pain DETECT Questionnaire and Short-From McGill Pain Questionnaire, are filled out by subjects.
Thereafter, the thickness and echogenicity of the muscles and connective tissue of the lower back are measured using an ultrasonic diagnostic imaging apparatus. Intervene only once.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects with low back pain for more than 6 months
Key exclusion criteria
The subjects with a history of trauma or surgery on the lumbar or lower limbs.
The subjects with lower extremity pain.
The subjects with a score of 19 or more of Pain DETECT Questionnaire.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Ushida |
Organization
Mie University Graduate School of Medicine
Division name
Anesthesiology and Critical Care Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, Mie
TEL
059-231-5031
u-kenta@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Hiramatsu |
Organization
Mie University Graduate School of Medicine
Division name
Anesthesiology and Critical Care Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, Mie
TEL
059-231-5031
Homepage URL
masuika@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie-University
Institute
Department
Personal name
Funding Source
Organization
Mie-University
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
Mie university hospital, the clinical research and development center
Address
2-174 Edobashi, Tsu city, Mie
Tel
059-231-5246
kk-sien@mo.medic.mie-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
| 2019 | Year | 10 | Month | 12 | 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
| 2019 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043637
| 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 |
