UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040595 |
|---|---|
| Receipt number | R000046329 |
| Scientific Title | Lumber-pelvic intersegmental coordination and variability during work-related activity by individuals with low back pain: Effect of object weight variation |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2020/05/30 22:55:21 |
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Basic information
Public title
Lumber-pelvic intersegmental coordination and variability during work-related activity by individuals with low back pain: Effect of object weight variation
Acronym
Lumber-pelvic intersegmental coordination and variability during work-related activity by individuals with low back pain
Scientific Title
Lumber-pelvic intersegmental coordination and variability during work-related activity by individuals with low back pain: Effect of object weight variation
Scientific Title:Acronym
Lumber-pelvic intersegmental coordination and variability during work-related activity by individuals with low back pain
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined the coordination and variability between lumbar and pelvic angles during the lifting of objects of various weights.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum ROM for lumbar, pelvic and hip flexion
Peak velocity of lumbar, pelvic and hip flexion
Peak velocity of lumbar, pelvic and hip extension
Mean absolute relative phase angle (MARP)
mean deviation phase (DP)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Pain that present from rib lower edge to gluteal fold for more than one day.
LBP that appears when lift a heavy object during work.
LBP duration of > 3 months.
Score of 10mm or more on a visual analogue scale for pain intensity.
Key exclusion criteria
Previous a diagnosis of spinal disease.
Presence of neurological symptoms of lower limb.
Pain that also present in limb joints other than lumber region.
Previous a diagnosis of neurological disorder such as cerebrovascular disorder.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ren |
| Middle name | |
| Last name | Fujii |
Organization
Graduate School of Health Science, Kio University
Division name
Department of Neurorehabilitation
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
070-1523-8136
ren08150815@gmail.com
Public contact
Name of contact person
| 1st name | Ren |
| Middle name | |
| Last name | Fujii |
Organization
Graduate School of Health Science, Kio University
Division name
Department of Neurorehabilitation
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
070-1523-8136
Homepage URL
ren08150815@gmail.com
Sponsor or person
Institute
Department of Neurorehabilitation, Graduate School of Health Science, Kio University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurorehabilitation, Graduate School of Health Science, 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
Department of Neurorehabilitation, Graduate School of Health Science, Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
070-152308136
ren08150815@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
| 2020 | Year | 06 | Month | 10 | 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
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects perform lifting an object.
The weight of the box was varied based on 10%, 30% and 50% of the subject's body weight.
Following several practice trials, the subjects performed the movement task five times for each weight condition.
Management information
Registered date
| 2020 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046329
