UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038144
Receipt number R000043436
Scientific Title Effectiveness of Self-management App for low back pain - Randomized controlled trial
Date of disclosure of the study information 2019/09/29
Last modified on 2019/09/28 08:58:17

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Basic information

Public title

Effectiveness of Self-management App for low back pain - Randomized controlled trial

Acronym

Effectiveness of Self-management App for low back pain

Scientific Title

Effectiveness of Self-management App for low back pain - Randomized controlled trial

Scientific Title:Acronym

Effectiveness of Self-management App for low back pain

Region

Japan


Condition

Condition

Chronic low back pain

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness the self-management App for low back pain with a randomized controlled trial (RCT).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Low back pain intensity (Numerical Rating Scale)
Brief Pain Inventory

Baseline, 3 month, 6 month

Key secondary outcomes

Disability due to low back pain (Roland Morris Disability Questionnaire)
Presenteeism (QQ-method)
Seeking care / Medicine intake
Kinesiophobia (Tampa Scale for Kinesiophobia 11)
Depresiive symptom (Center for Epidemiologic Studies Depression Scale 10)
Lifestyle factors (Self-reported)

Baseline, 3 month, 6 month

Adherence: Data from App
Other: Satisfaction and opinions about App (6 month follow-up)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Under support from physical therapists, participants set the long-term and short-term goal, monitor their own pain and physical activity, and execute the solution of low back pain. Participants receive chat support from physical therapists. The duration of intervention is 6 month.

Physical therapists give participants solutions of low back pain such as back pain education , exercise, cognitive behavioral therapy, stress coping, and ergonomic intervention. Physical therapists have 3 or more years clinical experience and abundant experience of chat support.

Interventions/Control_2

E-mail news about low back pain (Once in a week)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

eldercare worker
chronic low back pain lasting 3 month or more
NRS: 4 or more
own smartphones or tablets

Key exclusion criteria

fracture, trauma, Infectious spondylitis, cancer, back pain due to internal disorder
difficult to join the study due to diseases
pregnant

Target sample size

102


Research contact person

Name of lead principal investigator

1st name Rei
Middle name
Last name Ono

Organization

Kobe University Graduate School of Health Sciences

Division name

Department of Public Health

Zip code

654-0142

Address

7-10-2, Tomogaoka, Suma, Kobe

TEL

078-796-4515

Email

ono@phoenix.kobe-u.ac.jp


Public contact

Name of contact person

1st name Yamato
Middle name
Last name Tsuboi

Organization

Kobe University Graduate School of Health Sciences

Division name

Department of Community Health Sciences

Zip code

654-0142

Address

7-10-2, Tomogaoka, Suma, Kobe

TEL

078-796-4515

Homepage URL


Email

yt.green1@gmail.com


Sponsor or person

Institute

Kobe University Graduate School of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology, The Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

BackTech Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethics Committee of Kobe University Graduate School of Health Sciences

Address

7-10-2, Tomogaoka, Suma, Kobe

Tel

078-796-4502

Email

syomu2@ams.kobe-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 09 Month 29 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 09 Month 27 Day

Date of IRB


Anticipated trial start date

2019 Year 10 Month 15 Day

Last follow-up date

2020 Year 04 Month 14 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 09 Month 28 Day

Last modified on

2019 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name