UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039723 |
|---|---|
| Receipt number | R000045303 |
| Scientific Title | Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis. |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2021/03/08 00:07:11 |
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Basic information
Public title
Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Acronym
Central pain modulation in osteoarthritis patients.
Scientific Title
Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Scientific Title:Acronym
Central pain modulation in osteoarthritis patients.
Region
| Japan |
Condition
Condition
Knee and hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyse of conditions of central pain modulation and investigate exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
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
Physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standard treatment and exercise (walking)
Three times per week for 3 months
Interventions/Control_2
Standard treatment
For 3 months
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
At least 1 on the Kellgren/Lawrence scale for knees or hips
Experienced near-daily knee or hip pain (ie, pain that was present for more than 4 days per week and was rated as 2 or higher on a 0 to 10 scale) for at least 6 months
Self-reported knee or hip pain was the primary musculoskeletal complaint at the time of recruitment
Aged 40 years or older
Key exclusion criteria
Having Systemic inflammatory disease
Cognitive impairment affecting the ability to cooperate with testing
Leg pain referred from the lumbar disease
Experienced serious medical comorbidities (eg, congestive heart failure, cerebrovascular disease, cancer)
Using centrally acting medications such as opioid
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maehara Orthopedic Rehabilitation Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
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）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 06 | 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
| 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
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045303
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| Registered date | File name |
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