UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038850 |
|---|---|
| Receipt number | R000044306 |
| Scientific Title | Effects of regular exercise on pain sensitivity and subjective pain symptom in people with chronic pain |
| Date of disclosure of the study information | 2019/12/13 |
| Last modified on | 2022/12/21 07:42:14 |
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Basic information
Public title
Effects of regular exercise on pain sensitivity and subjective pain symptom in people with chronic pain
Acronym
Regular exercise-induced hypoalgesia
Scientific Title
Effects of regular exercise on pain sensitivity and subjective pain symptom in people with chronic pain
Scientific Title:Acronym
Regular exercise-induced hypoalgesia
Region
| Japan |
Condition
Condition
Chronic neck/shoulder, low back and knee pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of regular exercise on pain sensitivity and subjective pain symptoms in people with chronic musculoskeletal pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Subjective pain
2) Quantitative sensory testing
Key secondary outcomes
1) Physical disability
2) Physical activity
3) Mood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic exercise (cycling) three times per week for 4 weeks
Interventions/Control_2
No treatment
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We will include persons with neck and shoulder pain, low back pain or knee pain lasted > 3 months and their maximum intensity > 20 mm on VAS for a week.
Key exclusion criteria
Receiving medical treatment for pain, taking medication, pregnancy, history of surgery, cardiovascular or metabolic disease, contraindication to exercise.
Target sample size
100
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
Amagasaki Daimotsu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Medical and Health Research Involving Human Subjects on Faculty of Rehabilitation, Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180 JAPAN
Tel
(078)974-4127
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
神戸学院大学（兵庫県）/Kobe Gakuin University（Hyogo）、尼崎だいもつ病院（兵庫県）/Amagasaki Daimotsu Hospital（Hyogo）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 13 | 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
82
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 11 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044306
