UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044437
Receipt number R000050765
Scientific Title Relationship between the contact area of the first lying position and low back pain
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/04 17:57:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Relationship between the contact area of the first lying position and low back pain

Acronym

Relationship between the contact area of the first lying position and low back pain

Scientific Title

Relationship between the contact area of the first lying position and low back pain

Scientific Title:Acronym

Relationship between the contact area of the first lying position and low back pain

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the difference in body pressure and contact area between the initial sleeping posture during sleep and the lying posture depending on the presence or absence of low back pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body pressure, contact area, presence or absence of low back pain, initial sleeping posture

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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Lying posture (4 patterns)

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult

Key exclusion criteria

None

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Mamiko
Middle name
Last name Kamoshida

Organization

Hokkaido University of Science

Division name

Faculty of Health Science

Zip code

006-8585

Address

7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan

TEL

0116887194

Email

kamoshida-m@hus.ac.jp


Public contact

Name of contact person

1st name Mamiko
Middle name
Last name Kamoshida

Organization

Hokkaido University of Science

Division name

Faculty of Health Science

Zip code

0068585

Address

7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan

TEL

0116887194

Homepage URL


Email

kamoshida-m@hus.ac.jp


Sponsor or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University of Science

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

Hokkaido University of Science

Address

7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan

Tel

0116887194

Email

kamoshida-m@hus.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

2021 Year 07 Month 01 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

2021 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2023 Year 05 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

2021 Year 06 Month 04 Day

Last modified on

2021 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050765


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name