UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052144 |
|---|---|
| Receipt number | R000059513 |
| Scientific Title | Pathophysiology of chronic low back pain and short-term/long-term effects of exercise therapy, along with factors influencing its effects |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2023/09/07 17:40:12 |
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Basic information
Public title
Pathophysiology of chronic low back pain and short-term/long-term effects of exercise therapy, along with factors influencing its effects
Acronym
Pathophysiology of chronic low back pain and effects of exercise therapy
Scientific Title
Pathophysiology of chronic low back pain and short-term/long-term effects of exercise therapy, along with factors influencing its effects
Scientific Title:Acronym
Pathophysiology of chronic low back pain and effects of exercise therapy
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the pathophysiology and the factors influencing the EIH (exercise-induced hypoalgesia) effect as well as the long-term effects of exercise therapy in patients with chronic low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Numerical Rating Scale
Pressure pain threshold
Temporal summation of pain
Conditioned pain modulation
Key secondary outcomes
Central sensitization inventory
Pain catastrophizing scale
Tampa scale for kinesiophobia
Hospital anxiety and depression scale
Oswestry disability index
Pain self-efficacy questionnaire
Athens insomnia scale
EuroQol 5-dimention 5-level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic exercise (20 minutes)
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Low back pain lasting more than 3 months
(2)Low back pain at the time of initial evaluation greater than VAS 30 mm
Key exclusion criteria
(1)Patients with lower limb pain equal to or greater than low back pain
(2)Patients who have undergone back surgery within the past year
(3)Patients with significant cognitive dysfunction that would affect the examination
(4)Patients with systemic inflammatory diseases
(5)Patients with severe mental, cardiovascular, respiratory, or metabolic diseases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, Japan
TEL
(078)974-1551
matsubar@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, Japan
TEL
(078)974-1551
Homepage URL
matsubar@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Gakuin University
Address
518, Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel
(078)974-1551
ethic@reha.kobegakuin.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
田中整形外科（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 07 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059513
