UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Title of the study (Brief title)	Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Region	Japan

Condition
Condition	primary lymphedema
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess combined physical therapy for primary lymphedema and revise its treatment guideline
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of volume of lower extremity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	group intensive combined physical therapy
Interventions/Control_2	group maintenance combined physical therapy
Interventions/Control_3	group of reinforcement of compression therapy 3 times a week, 2weeks
Interventions/Control_4	group of reinforcement of lymph-drainage therapy 3 times a week, 2weeks
Interventions/Control_5	group of reinforcement of kinesi therapy 3 times a week, 2weeks
Interventions/Control_6	standard therapy every day, 2 weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. primary secondary lymphedema of unilateral leg 2. patient without intensive combined physical therapy within three months 3. more than 20 years
Key exclusion criteria	1. edema due to other causes 2. edema of upper extremities or body 3. stage 0-lymphedema cancer patient 4. expected life time less than one years
Target sample size	5

Research contact person
Name of lead principal investigator	Tetsuya Kitagawa
Organization	Tokushima University Hospital
Division name	Cardiovascular surgery
Address	2-50-1, Kuramotocho, Tokushima-City, Tokushima, 770-8503,Japan
TEL	088-633-7581
Email	kitagawa@tokushima-u.ac.jp

Public contact
Name of contact person	Tetsuya Kitagawa
Organization	Tokushima University Hospital
Division name	Cardiovascular surgery
Address	2-50-1, Kuramotocho, Tokushima-City, Tokushima, 770-8503,Japan
TEL	088-633-7581
Homepage URL
Email	kitagawa@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 01 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018362