UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049798 |
|---|---|
| Receipt number | R000056716 |
| Scientific Title | Comparison of the Intramuscular Circulation of Lumbar Multifidus in Subjects with and without Low Back Pain in Trunk Extension and Extended Exercise Position. |
| Date of disclosure of the study information | 2023/05/12 |
| Last modified on | 2025/04/07 18:10:14 |
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Basic information
Public title
Comparison of the Intramuscular Circulation of Lumbar Multifidus in Subjects with and without Low Back Pain in Trunk Extension and Extended Exercise Position
Acronym
Comparison of the Intramuscular Circulation of Lumbar Multifidus in Subjects with and without Low Back Pain in Trunk Extension and Extended Exercise Position
Scientific Title
Comparison of the Intramuscular Circulation of Lumbar Multifidus in Subjects with and without Low Back Pain in Trunk Extension and Extended Exercise Position.
Scientific Title:Acronym
Comparison of the Intramuscular Circulation of Lumbar Multifidus in Subjects with and without Low Back Pain in Trunk Extension and Extended Exercise Position
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in relative circulation over time on the lumbar multifidus in subjects with and without low back pain (LBP) in trunk extension and extended exercise position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Near-infrared spectroscopy (NIRS) will be used to non-invasively measure total hemoglobin (Total-Hb), oxygenated hemoglobin (Oxy-Hb), and deoxygenated hemoglobin (Deoxy-Hb) of lumbar multifidus at L5-S1 segment. All measurements will be obtained in neutral position, 20 degree of trunk extended position, and extended exercise position in standing. Subjects will be asked to move into either trunk extension or extended exercise position from starting (neutral) position.The measurements of Total-Hb and Oxy-Hb were compared at -3 seconds (neutral position) and 10 seconds of in each trunk extended and extended exercise position in standing.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects will be asked to move into either trunk extension or extended exercise position from starting (neutral) position to maintain these positions for 10 seconds.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with LBP for more than 3 months
Key exclusion criteria
a history of lumbar surgery, immunological diseases (rheumatism, etc.), and neurological symptoms of the lower extremities.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | masaru |
| Middle name | |
| Last name | kanda |
Organization
niigata university of health and welfare
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
9503198
Address
1398 shimai, Kita-ku, Niigata, Niigata, Japan
TEL
0252574621
kanda@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | masaru |
| Middle name | |
| Last name | kanda |
Organization
Niigata University of Health and Welfare
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
9503198
Address
1398 shimai, Kita-ku, Niigata, Niigata, Japan
TEL
0252574621
Homepage URL
kanda@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 shimai, Kita-ku, Niigata, Niigata, Japan
Tel
0252574621
kanda@nuhw.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 | 05 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jspineres/14/6/14_2023-0620/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
under the review
Number of participants that the trial has enrolled
30
Results
The intramuscular circulation of lumbar multifidus increased with trunk extension, but the circulation increased more with extending exercise in both the LBP and non-LBP groups.
Results date posted
| 2023 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twelve subjects (21.2 years) with LBP for the past three months and 18 healthy subjects (21.1 years) without LBP were recruited.
Participant flow
Female university student volunteers were subjected to a questionnaire on low back pain.
Those who had back pain for the past 3 months or more and still had persistent pain were defined as back pain group, and those who had no symptoms were defined as no back pain group.
Adverse events
none
Outcome measures
Near-infrared spectroscopy (NIRS) was used to non-invasively measure oxygenated hemoglobin (Oxy-Hb), deoxygenated hemoglobin (Deoxy-Hb), and total hemoglobin (Total-Hb) of the lumbar multifidus at the L5-S1 segment. All measurements were obtained in the neutral position, at trunk extension of 20 degrees, and during trunk extending exercise while standing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056716
