UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045516 |
|---|---|
| Receipt number | R000051965 |
| Scientific Title | Consideration of the validity of the medicine treatment of artificial knee joint replacement chronic postsurgical pain (searching study) |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2024/03/22 11:52:36 |
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Basic information
Public title
Consideration of the validity of the medicine treatment of artificial knee joint replacement chronic postsurgical pain (searching study)
Acronym
chronic postsurgical pain in TKA(medicine treatment)
Scientific Title
Consideration of the validity of the medicine treatment of artificial knee joint replacement chronic postsurgical pain (searching study)
Scientific Title:Acronym
chronic postsurgical pain in TKA(medicine treatment)
Region
| Japan |
Condition
Condition
chronic postsurgical pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic postsurgical pain in TKA to OA will be the factor on which patient satisfaction is hung, and it's still lacking in evidence in what kind of medicine treatment there is a validity. It's the purpose of this research to make the validity of the medicine treatment clear. I can think these inspection results will be some help of establishment of a remedy to chronic postsurgical pain and improvement of treatment results of TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change which is sharp pain VAS in 3 months after the medicine treatment starting time and starting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TRAMCET Combination Tablets
Interventions/Control_2
Cymbalta Capsules
Interventions/Control_3
TRAMCET Combination Tablets and Cymbalta Capsules
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
1)The patient who carried out TKA to OA
2)The patient who fills following all which is a definition of chronic postsurgical pain as of 3 months after an operation
1,The pain appears after surgery-like operation.
2,The pain is continuing for 2 months at least after an operation of TKA to OA.
3,The pain by the other cause can be excluded.
4,The pain besides the operation part which existed before the way can be excluded.
3)Patient who possesses sharp pain VAS >= 30 (0-100) as of 3 months after an operation
4)the patient of whom walking is independent
5)the age of the time of the agreement merit, more than 20-year-old patient(I don't ask about the gender.)
6)the patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research
Key exclusion criteria
1)the patient who is planning to carry out TKA in simultaneousness of left and right
2)patient with a spirit disease
3)patient with taboo and TRAMCET Combination Tablets and Cymbalta Capsules
4)additionally the patient who judged that a study person in charge was unsuitable as a subject of research person
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8266
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8266
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
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
The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address
1-3-1 Kudanminami, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec4@mirai-iryo.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
| 2021 | Year | 10 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051965
