UMIN-CTR Clinical Trial

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
Institute	Morinomiya University of Medical Sciences
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043818