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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030086
Receipt No. R000034347
Scientific Title Effectiveness of Short-term Exercise Therapy for Chronic Low Back Pain with Lumbar Support; Randomized Controlled Trial
Date of disclosure of the study information 2017/11/22
Last modified on 2017/11/22

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Basic information
Public title Effectiveness of Short-term Exercise Therapy for Chronic Low Back Pain with Lumbar Support; Randomized Controlled Trial
Acronym Synergetic Effects of Exercise and Lumbar Support for Chronic Low Back Pain Patients
Scientific Title Effectiveness of Short-term Exercise Therapy for Chronic Low Back Pain with Lumbar Support; Randomized Controlled Trial
Scientific Title:Acronym Synergetic Effects of Exercise and Lumbar Support for Chronic Low Back Pain Patients
Region
Japan

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

Objectives
Narrative objectives1 Examining whether effects of exercise therapy and wearing lumbar support on pain, body function (trunk muscle strength and muscle mass), mental function (anxiety and depression and catastrophic thinking), quality of life (QOL) and cost effectiveness in low back pain patients will be greater than those without support.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the difference of Numerical Rating Scale
(At 2 weeks, at 1 month, 3 months, 6 months and 12 months after treatment)
Key secondary outcomes muscle mass
trunk muscle strength
sagittal alignment
multifidus muscle compression ratio
Physical Activity( Internatilnal Physical Activity Questionnaire Japanese Ver.)
Japanese Orthopedic Association Back Pain Evaluation Qustionnaire
Roland-Morris Disability Questionnaire
Pain Catastrophizing Scale
Hospital Anxiety and Depression Scale
Tampa Scale for Kinesiophobia
36-Item Short Form Health Survey
Euro Qol 5 Dimension 5 level version
treatment satisfaction
cost effectiveness
(At 2 weeks, at 1 month, 3 months, 6 months and 12 months after treatment)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 Wearing lumbar support group (5 times a week for 2 weeks)
Under wearing lumbar support
Supervised trunk and legs exercises
Manual therapy
walking or cycle ergo-meter (20 to 30 minutes)
home exercise program (trunk and legs exercise, stretching, walking)
Interventions/Control_2 Control group(5 times a week for 2 weeks)
do not setting lumbar support
Supervised trunk and legs exercises
Manual therapy
walking or cycle ergo-meter (20 to 30 minutes)
home exercise program (trunk and legs exercise, stretching, walking)
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
100 years-old >
Gender Male and Female
Key inclusion criteria low back pain continuing for twelve weeks and more
Key exclusion criteria acute low back pain
dementia
previous spine surgery
a history of psychiatric illness
trauma, insurance relations have a problem
Target sample size 82

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamoru Kawakami
Organization Wakayama Medical University Kihoku hospital
Division name Spine Care Center
Zip code
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL 0736-22-0066
Email kawakami@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Nakagawa
Organization Wakayama Medical University Kihoku Hospital
Division name Spine Care Center
Zip code
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL 0736-22-0066
Homepage URL
Email ptnaka@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 11 Month 22 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2017 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034347

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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