UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043233 |
|---|---|
| Receipt number | R000049338 |
| Scientific Title | The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief. |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/04/27 13:30:02 |
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Basic information
Public title
The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Acronym
The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Scientific Title
The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Scientific Title:Acronym
The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether pre-operative rehabilitation is effective in relieving postoperative pain for total joint arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain VAS
NSAIDs, Opioid
Laboratory data
Range of motion of the joint
Postop. 1,4,7,14,21,28,56,72days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
A group that does not perform the above rehabilitation as before.
Interventions/Control_2
A group that loosens contracted muscles and joints, focusing on stretching and gymnastics of periarticular muscles before surgery (2-4wks)
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo total joint arthroplasty due to osteoarthritis
Key exclusion criteria
*a history of surgery on this joint in the past
*Fracture cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedics
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city, Nara
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedics
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city, nara
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital
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
Shiraniwa Hospital
Address
6-10-1 Shiraniwadai Ikoma-city Nara
Tel
0743-70-0022
kenpiecekenpiece@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | 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 | 02 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049338
