UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030086 |
|---|---|
| Receipt number | 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 | 2023/05/29 08:25:57 |
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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 | Mamoru |
| Middle name | |
| Last name | Kawakami |
Organization
Wakayama Medical University Kihoku hospital
Division name
Spine Care Center
Zip code
649-7113
Address
219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL
0736-22-0066
kawakami@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakagawa |
Organization
Wakayama Medical University Kihoku Hospital
Division name
Spine Care Center
Zip code
649-7113
Address
219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL
0736-22-0066
Homepage URL
ptnaka@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Wakayama, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 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
51
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
| 2017 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034347
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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