UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043501 |
|---|---|
| Receipt number | R000049672 |
| Scientific Title | Effects of lower limb vibration on pain and functional recovery after total hip arthroplasty |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2022/09/03 16:54:23 |
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Basic information
Public title
Effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Acronym
Effects of vibration in patients after total hip arthroplasty
Scientific Title
Effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Scientific Title:Acronym
Effects of vibration in patients after total hip arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of hip
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hip pain
Swelling
Key secondary outcomes
Muscle stiffness
Inflammation
Physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Interventions/lower limb vibration
Lower limb vibration is applied at a frequency of 50 Hz for 10 min/day for 7 days after surgery
Interventions/Control_2
Control/thermotherapy
Hot pack is applied for 10 min/day for 7 days after surgery
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with hip osteoarthritis who are scheduled for THA
Key exclusion criteria
rheumatoid arthritis
femoral head necrosis
ipsilateral hip surgery
neurological impairment cardiovascular disease
severe knee OA
severe cognitive impairment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Ikutomo |
Organization
Masuhara Clinic
Division name
Department of Rehabilitation
Zip code
530-0042
Address
3-4-2, Tenmabashi, Kita-ku, Osaka 530-0042, Japan
TEL
0663580200
hisashiikutomo@gmail.com
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Ikutomo |
Organization
Mauhara Clinic
Division name
Department of Rehabilitation
Zip code
530-0042
Address
3-4-2, Tenmabashi, Kita-ku, Osaka 530-0042, Japan
TEL
0663580200
Homepage URL
hisashiikutomo@gmail.com
Sponsor or person
Institute
Masuhara Clinic
Institute
Department
Personal name
Funding Source
Organization
Dream factory incorporated
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, shimamimati, kita-ku, niigata city, Niigata
Tel
025-257-4455
rinri@nuhw.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
医療法人 増原クリニック （大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 03 | 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
30
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049672
