UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of Jiggling for Osteoarthritis of the Hip. -Multi-center Study-
Title of the study (Brief title)	Jiggling for Hip OA
Region	Japan

Condition
Condition	Osteoarthritis of the hip
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the utility of jiggling for osteoarthiritis of the hip
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	JOA score (3months, 6months, 1year,2years)
Key secondary outcomes	Joint space of radiogram (3months, 6months, 1year,2years)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Osteoarthritis of the Hip
Key exclusion criteria	History of Total Hip Arthroplasty
Target sample size	200

Research contact person
Name of lead principal investigator	Shigeru Mitani
Organization	Kawasaki Medical School
Division name	Department of Bone and Joint Surgery
Address	577, Matsushima, Kurashiki City, Okayama
TEL	086-462-1111
Email	mitanibb@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Shigeru Mitani
Organization	Kawasaki Medical School
Division name	Department of Bone and Joint Surgery
Address	577, Matsushima, Kurashiki City, Okayama
TEL	086-462-1111
Homepage URL
Email	mitanibb@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
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	川崎医科大学附属病院(岡山県)、柳川リハビリテーション病院(福岡県)、神奈川リハビリテーション病院(神奈川県)、島根大学(島根県)、市立ひらかた病院(大阪府)、銀座医院(東京都)、京都第一赤十字病院(京都府)、久留米大学医療センター(福岡県)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 10 Month 01 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	Hip Joint Space from radiogram Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire(JHEQ)
Other related information	Hip Joint Space and JHEQ Score would be examined by observing the patients undergoing conservative treatment for osteoarthritis of the hip.

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026926