UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044360
Receipt No. R000050661
Scientific Title Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis: a randomized controlled trial
Date of disclosure of the study information 2021/06/01
Last modified on 2021/09/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis
Acronym Effects of home-exercise programs in patients with hip osteoarthritis
Scientific Title Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis: a randomized controlled trial
Scientific Title:Acronym Effects of home-exercise programs in patients with hip osteoarthritis
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 low-intensity vibration vs foam rolling on pain and functional recovery in patients with hip osteoarthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Hip pain
Key secondary outcomes hip function
motor function
physical activity

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Interventions/low-intensity vibration
Low-intensity vibration is applied at a frequency of 50 Hz for 2 min * 3 positions/day for 1 month
Interventions/Control_2 Interventions/foam rolling
Foam rolling is applied for 2 min * 3 positions/day for 1 month
Interventions/Control_3 Control/exercise
Hip muscle training is applied for 2 min * 3 programs/day for 1 month
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
80 years-old >
Gender Male and Female
Key inclusion criteria patients with hip osteoarthritis
Key exclusion criteria normal hip
acetabular dysplasia
severe hip OA
rheumatoid arthritis
femoral head necrosis
ipsilateral hip surgery
total hip arthroplasty
neurological impairment cardiovascular disease
severe knee OA
severe cognitive impairment
pain around the hip joint for less than 3 months
hip pain intensity of 40 or lower on a 100-mm visual analog scale
Target sample size 60

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
TEL 0663580200
Email ikutomo@fruition.co.jp

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
TEL 0663580200
Homepage URL
Email ikutomo@fruition.co.jp

Sponsor
Institute Masuhara Clinic
Institute
Department

Funding Source
Organization Dream factory incorprated
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 06 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 28 Day
Date of IRB
2021 Year 06 Month 30 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2023 Year 06 Month 01 Day
Date of closure to data entry
2023 Year 08 Month 01 Day
Date trial data considered complete
2023 Year 08 Month 31 Day
Date analysis concluded
2023 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 28 Day
Last modified on
2021 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050661

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.