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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name