UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051857 |
|---|---|
| Receipt number | R000059171 |
| Scientific Title | Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis? |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2023/08/08 03:04:14 |
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Basic information
Public title
Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis?
Acronym
Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis?
Scientific Title
Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis?
Scientific Title:Acronym
Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis?
Region
| Asia(except Japan) |
Condition
Condition
pretest-posttest
Classification by specialty
| Medicine in general | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Are there differences between the Ottawa Panel evidence-based clinical guidelines on pain, function, and psychological factors in individuals with knee osteoarthritis?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain
Key secondary outcomes
Performance
Psychological variables
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pilates exercise group = 23;
Interventions/Control_2
strengthening exercise group = 22;
Interventions/Control_3
aerobic exercise group = 23
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
being 60 years of age or older;
experiencing knee pain on most days of the past month;
average knee pain in the last week between 3 and 7 on an 11-point numeric rating scale (NRS);
Key exclusion criteria
having had joint replacement surgery or arthroscopic surgery on the affected side of the knee; other surgery on lower limbs within the past 6 months; severe deformity of lower limbs (e.g., knee varus or knee valgus); having health problems that can easily induce adverse events during home exercise, such as uncontrolled high blood pressure, a myocardial infarction, cerebral infarction, unstable angina, arrhythmia, severe vision problems, or neurological dysfunction
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | amir |
| Middle name | |
| Last name | letafatkar |
Organization
kharazmi university
Division name
sports sciences
Zip code
54543534
Address
kzraj
TEL
00982634512001
letafatkaramir@yahoo.com
Public contact
Name of contact person
| 1st name | amir |
| Middle name | |
| Last name | letafatkar |
Organization
kharazmi university
Division name
sport medicine
Zip code
24341543511
Address
karaj
TEL
00982634512001
Homepage URL
letafatkaramir@yahoo.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
kharazmi university
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
kharazmi university
Address
karaj
Tel
00982634512009
letafatkaramir@yahoo.com
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
| 2023 | Year | 08 | Month | 08 | 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
75
Results
-
Results date posted
| 2023 | Year | 08 | Month | 08 | Day |
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059171
