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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041037
Receipt No. R000046866
Scientific Title Open-label, randomized, parallel group trial to evaluate the effect on work productivity by patient education and strengthening exercise therapy in patients with chronic low back pain
Date of disclosure of the study information 2020/07/09
Last modified on 2020/07/08

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Basic information
Public title A prospective study to explore the effect on work productivity when
strengthening exercise therapy in patients with chronic low back pain
Acronym A prospective study to explore the effect on work productivity when
strengthening exercise therapy in patients with chronic low back pain
Scientific Title Open-label, randomized, parallel group trial to evaluate the effect on work
productivity by patient education and strengthening exercise therapy in patients
with chronic low back pain
Scientific Title:Acronym Open-label, randomized, parallel group trial to evaluate the effect on work
productivity by patient education and strengthening exercise therapy in patients
with chronic low back pain
Region
Japan

Condition
Condition chronic low back pain
Classification by specialty
Orthopedics Anesthesiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to evaluate the effect on work productivity by patient education with online-video and exercise therapy with mobile application in chronic low back pain patients who have medical treatment.
The observational period is for 12 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of work productivity (QQ method)
Key secondary outcomes 1) the changes of work productivity (WPAI:GH)
2) the changes of low back pain level (NRS), stiff shoulders level and improvement in self evaluations of low back pain and stiff shoulders
3) the change of QoL
(specific low back pain QoL:RDQ-24, health-related QoL:EQ-5D-5L)
4) the changes of fear-avoidance beliefs (TSK-11)
5) the changes of depression level (K-6)
6) the changes of the drug doses
7) the change ratio of visiting medical institutions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Strengthening exercise therapy group
Interventions/Control_2 Non-strengthening exercise therapy group
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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who have low back pain more than three months
2. Ages 20 to 64
3. Patients who have medications for low back pain.
4. Patients who have ability to walk without assistance
5. Patients who will work more than three days a week
6. Patients who have ability to use of mobile communication devices
Key exclusion criteria 1. Patients who have the Red flags
2. Patient who are pregnant or wish to become pregnant
3. Patients who have radiculopathy
4. Patients who have strong opioids
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ko
Middle name
Last name Matsudaira
Organization The university of Tokyo Hospital
22nd Century Medical and Research center
Division name Musculoskeletal pain medical research & management section
Zip code 113-0033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-9545
Email kohart801@gmail.com

Public contact
Name of contact person
1st name Hiroichi
Middle name
Last name Yamamoto
Organization Mebix, Inc.
Division name Research promotion division
Zip code 107-0052
Address Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL 03-4362-4504
Homepage URL
Email hiroichi.yamamoto@mebix.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization Shionogi & Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Takahashi Clinic Ethics Committee
Address Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo
Tel 078-882-6432
Email kishimoto.satoshi@neues.co.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
2020 Year 07 Month 09 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 02 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 10 Day
Last follow-up date
2021 Year 03 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
2020 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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