UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038583 |
|---|---|
| Receipt number | R000043818 |
| Scientific Title | Physical therapy intervention for lateral femoral pain after trochanteric fracture-Effect of compression on the thigh- |
| Date of disclosure of the study information | 2019/11/20 |
| Last modified on | 2022/11/16 21:42:14 |
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Basic information
Public title
Physical therapy intervention for lateral femoral pain after trochanteric fracture-Effect of compression on the thigh-
Acronym
Physical therapy intervention for lateral femoral pain after trochanteric fracture-Effect of compression on the thigh-
Scientific Title
Physical therapy intervention for lateral femoral pain after trochanteric fracture-Effect of compression on the thigh-
Scientific Title:Acronym
Physical therapy intervention for lateral femoral pain after trochanteric fracture-Effect of compression on the thigh-
Region
| Japan |
Condition
Condition
Trochanteric fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of thigh compression on lateral femoral pain and develop effective physical therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gliding
Key secondary outcomes
Lateral femoral pain / Subcutaneous tissue thickness/ Range of motion / Muscle strength /Weight-bearing quantity of the lower limbs / Gait speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Compression of the thigh and assistance of muscles around the hip joint using elastic bandage.
Interventions/Control_2
Lightly wrap the elastic bandage.No pressure and assistance.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Postoperative patient with femoral trochanteric fracture
Key exclusion criteria
Severe dementia
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Physical therapy
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture 559-8611, Japan
TEL
06-6616-6911
shintarou.iimt@gmail.com
Public contact
Name of contact person
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Morinomiya University of Medical Sciences
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture 559-8611, Japan
TEL
06-6616-6911
Homepage URL
shintarou.iimt@gmail.com
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Suminoe ward
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture 559-8611, Japan
Tel
06-6616-6911
shintarou.iimt@gmail.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
加納総合病院/東大阪病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | 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
32
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
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043818
