UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052265 |
|---|---|
| Receipt number | R000059664 |
| Scientific Title | Central pain modulation and effects of exercise-induced hypoalgesia in patients with chronic pain |
| Date of disclosure of the study information | 2023/09/21 |
| Last modified on | 2024/02/19 08:59:34 |
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Basic information
Public title
Central pain modulation and analgesic effects of exercise in patients with chronic pain
Acronym
The analgesic effects of exercise in patients with chronic pain
Scientific Title
Central pain modulation and effects of exercise-induced hypoalgesia in patients with chronic pain
Scientific Title:Acronym
The effects of exercise-induced hypoalgesia in patients with chronic pain
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine conditions of central pain modulation and effects of exercise-induced hypoalgesia using quantitative sensory testing in patients with chronic 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, and conditioned pain modulation
Key secondary outcomes
Central sensitization inventory, pain catastrophizing scale, hospital anxiety and depression scale, pain disability assessment scale, pain self-efficacy questionnaire, and Athens insomnia scale
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pain lasting more than 3 months and worst pain intensity in the past week greater than NRS 3
Key exclusion criteria
Patients with systemic inflammatory diseases, skin damage at measurement site, cognitive dysfunction that would affect the examination, and severe cerebrovascular, cardiovascular, respiratory, or metabolic diseases.
Target sample size
60
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
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
中部国際医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 21 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059664
