UMIN-CTR Clinical Trial

Basic information
Public title	Effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Acronym	Effects of vibration in patients after total hip arthroplasty
Scientific Title	Effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Scientific Title:Acronym	Effects of vibration in patients after total hip arthroplasty
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to examine the effects of lower limb vibration on pain and functional recovery after total hip arthroplasty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hip pain Swelling
Key secondary outcomes	Muscle stiffness Inflammation Physical function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	Interventions/lower limb vibration Lower limb vibration is applied at a frequency of 50 Hz for 10 min/day for 7 days after surgery
Interventions/Control_2	Control/thermotherapy Hot pack is applied for 10 min/day for 7 days after surgery
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	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	patients with hip osteoarthritis who are scheduled for THA
Key exclusion criteria	rheumatoid arthritis femoral head necrosis ipsilateral hip surgery neurological impairment cardiovascular disease severe knee OA severe cognitive impairment
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Ikutomo
Organization	Masuhara Clinic
Division name	Department of Rehabilitation
Zip code	530-0042
Address	3-4-2, Tenmabashi, Kita-ku, Osaka 530-0042, Japan
TEL	0663580200
Email	hisashiikutomo@gmail.com

Public contact
Name of contact person	1st name Hisashi Middle name Last name Ikutomo
Organization	Mauhara Clinic
Division name	Department of Rehabilitation
Zip code	530-0042
Address	3-4-2, Tenmabashi, Kita-ku, Osaka 530-0042, Japan
TEL	0663580200
Homepage URL
Email	hisashiikutomo@gmail.com

Sponsor
Institute	Masuhara Clinic
Institute
Department

Funding Source
Organization	Dream factory incorporated
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Niigata University of Health and Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata University of Health and Welfare
Address	1398, shimamimati, kita-ku, niigata city, Niigata
Tel	025-257-4455
Email	rinri@nuhw.ac.jp

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	医療法人　増原クリニック　（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 03 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	30
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	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 03 Month 31 Day
Anticipated trial start date	2021 Year 02 Month 06 Day
Last follow-up date	2022 Year 05 Month 30 Day
Date of closure to data entry	2022 Year 05 Month 30 Day
Date trial data considered complete	2022 Year 05 Month 30 Day
Date analysis concluded	2022 Year 06 Month 17 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2022 Year 09 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049672