UMIN-CTR Clinical Trial

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	101
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	No longer recruiting
Date of protocol fixation	2020 Year 06 Month 02 Day
Date of IRB	2020 Year 06 Month 16 Day
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	2021 Year 01 Month 07 Day

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