UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041037 |
|---|---|
| Receipt number | 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 | 2021/01/07 11:48:09 |
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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
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
hiroichi.yamamoto@mebix.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046866
