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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name