UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002178 |
|---|---|
| Receipt number | R000002625 |
| Scientific Title | Multi-institutional prospective randomized controlled trial to compare the effects of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA. |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2013/07/10 20:48:25 |
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Basic information
Public title
Multi-institutional prospective randomized controlled trial to compare the effects of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA.
Acronym
Multi-institutional prospective randomized controlled trial to compare the effects of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA.
Scientific Title
Multi-institutional prospective randomized controlled trial to compare the effects of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA.
Scientific Title:Acronym
Multi-institutional prospective randomized controlled trial to compare the effects of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA.
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects and mechanisms of home-based exercise and intra-articular injection of hyaluronate acid for the knee OA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Japanse Knee Osteoarthritis Measure: JKOM
2) measurement of values of blood count, ESR, hs-CRP, HA, IL-1beta, IL-6, IL-10, IL1ra
Key secondary outcomes
range of motion, local swelling, warmth, hydrops of the affected knee.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
daily exercise for
1) muscle strength, and
2) range of motion of the knee
Interventions/Control_2
intra-articular injecion of hyaluronate acid.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with osteoarthritis of the knee
(Kellgren/Lawrence class II or III)
Key exclusion criteria
1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day to start the trial.
2) Patients who had done or planned operation against the knee.
3) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs.
4) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis.
5) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases.
6) Patients with cardiac, liver, or renal dysfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Iwase |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopaedics
Zip code
Address
3-3-20 Shinsuna, Koto, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Iwase |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
orthopaedics
Zip code
Address
3-3-20 Shinsuna, Koto, Tokyo
TEL
Homepage URL
iwase@juntendo.gmc.ac.jp
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 10 | Day |
Last modified on
| 2013 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002625
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
